Exact FDA event identifier

Event 95175

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

Event summary

Timeline bucket: August 02, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Ultradent Products, 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

3 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 3

Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52% filled by volume with 0.7 ¿m average particle size. Dentin Shades: fluorescent properties to replicate natural dentin. Available in 18 dentin shades. Enamel Shades: opalescent properties to replicate enamel. Available in 16 enamel shades including pearl, translucent, and opaque shades. Component: N/A

Z-3066-2024

Recall number: Z-3066-2024
Initiated: August 02, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Ultradent Products, Inc.
Quantity: 90

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulates

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to a manufacturing issue, red particulates present in the expressed composite.

Code information

Lot Code: Model No 1203; UDI-DI 00883205106094; Lot Number C1CF7; Expiration Date 04-Aug-2027

Distribution pattern

US: AZ, CA,CO,FL,GA,HI, IA, ID,IL,IN,KS,KY,LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, SC, TN, TX, UT, VA, VT, WI, WV Foreign: NL, DE, CH, CZ, FR, ES

device · product 2 of 3

Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 ¿m (by weight) with narrow upper limit particle distribution. Component: N/A

Z-3067-2024

Recall number: Z-3067-2024
Initiated: August 02, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Ultradent Products, Inc.
Quantity: 560

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulates

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to a manufacturing issue, red particulates present in the expressed composite.

Code information

Lot Code: Model No 4817; UDI-DI 00883205033680; Lot Number C1464; Expiration Date 30-Jun-2026

Distribution pattern

US: AZ, CA,CO,FL,GA,HI, IA, ID,IL,IN,KS,KY,LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, SC, TN, TX, UT, VA, VT, WI, WV Foreign: NL, DE, CH, CZ, FR, ES

device · product 3 of 3

Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 ¿m (by weight) with narrow upper limit particle distribution. Component: N/A

Z-3068-2024

Recall number: Z-3068-2024
Initiated: August 02, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Ultradent Products, Inc.
Quantity: 2450

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulates

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to a manufacturing issue, red particulates present in the expressed composite.

Code information

Lot Code: Model No 4757; UDI-DI 00883205028334; Lot Number C15C2; Expiration Date 31-May-2026

Distribution pattern

US: AZ, CA,CO,FL,GA,HI, IA, ID,IL,IN,KS,KY,LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, SC, TN, TX, UT, VA, VT, WI, WV Foreign: NL, DE, CH, CZ, FR, ES