Biologic Material, Dental
Dental · 21 CFR 872.3930
Other dental material with growth factors is a material, used with or without other devices, which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region.
Recent MDR events
12 adverse event reports on file
- EMDOGAIN, COURSEOct 9, 2025InjuryInstitut Straumann Ag0001222315-2025-002824
- EMDOGAIN, COURSEOct 8, 2025InjuryInstitut Straumann Ag0009613348-2025-015299
- STRAUMANN EMDOGAINJan 9, 2015OtherBiora Ab1222315-2015-00001
- STRAUMANN EMDOGAINJan 9, 2015OtherBiora Ab1222315-2015-00002
- STRAUMANN EMDOGAINJan 14, 2014OtherBiora Ab1222315-2014-00002
- STRAUMANN EMDOGAINNov 8, 2013OtherBiora Ab1222315-2013-00004
- STRAUMANN EMGOGAINJul 11, 2013OtherBiora Ab,1222315-2013-00003
- STRAUMANN EMDOGAINOct 25, 2012OtherBiora Ab1222315-2012-00017
- EMDOGAINDec 13, 2010OtherBiora Ab1222315-2010-00020
- EMDOGAINFeb 5, 2010InjuryBiora Ab1222315-2010-00005
Event type breakdown
Most-reported manufacturers
Recalls
7 recall events for this product code
- Straumann USA LLCOpen, ClassifiedNov 21, 2025
Emdogain;
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Z-0582-2026 · View FDA record ↗ - Straumann Manufacturing, Inc.TerminatedUnknown
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.
Z-1693-2018 · View FDA record ↗ - Straumann Manufacturing, Inc.TerminatedUnknown
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.
Z-1694-2018 · View FDA record ↗ - Straumann Manufacturing, Inc.TerminatedUnknown
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.
Z-1695-2018 · View FDA record ↗ - Straumann Manufacturing, Inc.TerminatedUnknown
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.
Z-1696-2018 · View FDA record ↗ - Straumann Manufacturing, Inc.TerminatedUnknown
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.
Z-1697-2018 · View FDA record ↗ - Straumann Manufacturing, Inc.TerminatedUnknown
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.
Z-1698-2018 · View FDA record ↗
Registered firms
7 firms currently registered for this product code
Biora Ab
MALMO Skane, SE
A+ Secure Packaging
La Vergne, TN, US
Lynch Biologics Llc
Franklin, TN, US
Sterigenics Radiation Technologies, Llc
San Diego, CA, US
Altasciences Cdmo Philadelphia, Llc
Harleysville, PA, US
Sterigenics Belgium Petit Rechain S.a.
Verviers Liege, BE
Institut Straumann Ag
BASEL Basel-Stadt, CH
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
1 premarket approvals for this product code