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.
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 6
Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
These labels are deterministic app interpretations, not FDA categories.
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Code information
Lot NP737, Syringe Blister Lot NA438A, Exp 3/31/2019; Lot PG628, Syringe Blister Lot NF819A, Exp 3/31/2019; Lot PY816, Syringe Blister Lot PT888C, Exp 1/31/2020; Lot NY939, Syringe Blister Lot, NA438A, Exp 3/31/2019
Distribution pattern
Distributed US Nationwide and Puerto Rico.
device · product 2 of 6
Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
These labels are deterministic app interpretations, not FDA categories.
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Code information
Lot LT830, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot LZ706, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot MG929, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot MT037, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot MZ441, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot NJ289, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot NJ579, Syringe Blister Lot NA438A, Exp 3/31/2019 Lot NP340, Syringe Blister Lot NA438A, Exp 3/31/2019
Distribution pattern
Distributed US Nationwide and Puerto Rico.
device · product 3 of 6
Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
These labels are deterministic app interpretations, not FDA categories.
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Code information
Lot MZ538, Syringe Blister Lot MG253B, Exp 9/4/2018 Lot NJ580, Syringe Blister Lot MG253B, Exp 9/30/2018 Lot NK215, Syringe Blister Lot NE101A, Exp 3/31/2019 Lot NP343, Syringe Blister Lot NE101A, Exp 3/31/2019
Distribution pattern
Distributed US Nationwide and Puerto Rico.
device · product 4 of 6
Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
These labels are deterministic app interpretations, not FDA categories.
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Code information
Lot NY938, Syringe Blister Lot MN843, Exp 11/30/2018 Lot NP738, Syringe Blister Lot NE101A, Exp 3/31/2019 Lot PG629, Syringe Blister Lot NK216, Exp 5/31/2019 Lot PY817, Syringe Blister Lot PT888C, Exp 1/31/2020
Distribution pattern
Distributed US Nationwide and Puerto Rico.
device · product 5 of 6
Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
These labels are deterministic app interpretations, not FDA categories.
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Code information
Lot LZ713, Syringe Blaster Lot LP632B, Exp 6/30/2018 Lot MZ542, Syringe Blaster Lot LP632B, Exp 6/30/2018 Lot MG933, Syringe Blaster Lot LP632B, Exp 6/30/2018 Lot MZ543, Syringe Blaster Lot MG253C, Exp 9/30/2018 Lot NJ581, Syringe Blaster Lot MG253C, Exp 9/30/2018 Lot NJ582, Syringe Blaster Lot NA438B, Exp 3/31/2019 Lot NP345, Syringe Blaster Lot NE101B, Exp 3/31/2019
Distribution pattern
Distributed US Nationwide and Puerto Rico.
device · product 6 of 6
Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
These labels are deterministic app interpretations, not FDA categories.
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Code information
Lot NZ535, Syringe Blaster Lot LP632A, Exp 6/30/2018 Lot PG631, Syringe Blaster Lot MX842B, Exp 2/28/2019 Lot NP739, Syringe Blaster Lot NE101B, Exp 3/31/2019 Lot PY818, Syringe Blaster Lot PT888A, Exp 1/31/2020
