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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74320

21 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 27, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ivoclar Vivadent, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

21 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 21

Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain

Z-0017-2017
Recall number
Z-0017-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
79 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U54839, expiration date: Jan 25 2018; Lot No: U51735, expiration date: Nov 11 2017; Lot No: U49940, expiration date: Nov 2 2017; Lot No: U44391, expiration date: Oct 19 2017 and Lot No: U39253, expiration date: Sep 20 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 2 of 21

Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain

Z-0018-2017
Recall number
Z-0018-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U44405, expiration date: Oct 19 2017; U39262, expiration date: Sep 20 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 3 of 21

Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain

Z-0019-2017
Recall number
Z-0019-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
60 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U52159, exp date: Mar 30 2018; U52107, exp date: Nov 16 2017; U44397, exp date: Oct 19 2017; and U39255, exp date: Sep 20 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 4 of 21

Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain

Z-0020-2017
Recall number
Z-0020-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
25 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U49960, Exp. date: Nov 2 2017; U44396, exp. date: Oct 19 2017; and U38897, exp date: Sep 16 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 5 of 21

Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

Z-0021-2017
Recall number
Z-0021-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
94 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U51483, exp date: Nov 10 2017; U43963, exp date: Nov 2 2017; U43927, exp. date: Nov 2 2017; and U38867, exp date: Sep 16 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 6 of 21

Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain

Z-0022-2017
Recall number
Z-0022-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
72 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U51512, exp date: Nov 10 2017; U44051, exp date: Oct 19 2017; U43988, exp date: Nov 2 2017; U43931, exp date: Nov 2 2017; and U39054 exp date: Sep 17 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 7 of 21

Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain

Z-0023-2017
Recall number
Z-0023-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
42 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U49683, exp date: Nov 2 2017; U49656, exp date: Nov 2 2017; and U39116, exp date: Sep 17 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 8 of 21

Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain

Z-0024-2017
Recall number
Z-0024-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U49659, exp date: Nov 2 2017; U43928, exp date: Oct 19 2017; and U38672, exp date: Sep 15 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 9 of 21

Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain

Z-0025-2017
Recall number
Z-0025-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U38746, exp date: Sep 15 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 10 of 21

Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain

Z-0026-2017
Recall number
Z-0026-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
43 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U49851, exp date: Nov 2 2017; U49838, exp date: Nov 2 2017; and U39117, Sep 17 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 11 of 21

Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain

Z-0027-2017
Recall number
Z-0027-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U39398, exp date: Sep 21 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 12 of 21

Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain

Z-0028-2017
Recall number
Z-0028-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U38751, exp date: Sep 15 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 13 of 21

Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain

Z-0029-2017
Recall number
Z-0029-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U38887, exp date: Sep 16 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 14 of 21

Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain

Z-0030-2017
Recall number
Z-0030-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
37 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U51611, exp date: Nov 11 2017; U50758, exp date: Nov 5 2017; U43929, exp date: Nov 5 2017; and U38834, exp date: Sep 16 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 15 of 21

Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain

Z-0031-2017
Recall number
Z-0031-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U44095, exp date: Oct 19 2017 and U38600, exp date: Sep 15 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 16 of 21

Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain

Z-0032-2017
Recall number
Z-0032-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
13 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U38627, exp date: Sep 15 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 17 of 21

Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain

Z-0033-2017
Recall number
Z-0033-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U38677, exp date: Sep 15 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 18 of 21

Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain

Z-0034-2017
Recall number
Z-0034-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U43930, exp date: Nov 2 2017 and U39238, exp date: Sep 20 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 19 of 21

Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain

Z-0035-2017
Recall number
Z-0035-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U38639, exp date: Sep 15 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 20 of 21

Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain

Z-0036-2017
Recall number
Z-0036-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U38680, exp date: Sep 15 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

device · product 21 of 21

Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain

Z-0037-2017
Recall number
Z-0037-2017
Initiated
May 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Code information

Lot No: U44402, expiration date: Oct 19 2017; V01767, expiration date: Jan 18 2018; U52968, expiration date: Jan 18 2018; U53010, expiration date: Nov 16 2017; and U38982, expiration date: Sep 17 2017

Distribution pattern

US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

Field note

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