Biologic Material, Dental
Regulation 872.3930
0510(k)s in 12 months (0 all time)
1recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in NQA
| Company | 510(k)s | Recalls |
|---|---|---|
| Straumann Manufacturing, Inc. | 0 | 6 |
| Straumann USA LLC | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2025 | Straumann USA LLC Emdogain;
Article Numbers: (1) 440.230V10, (2) 475.132V10; Open, Classified |
NQA | None listed |
| Mar 23, 2018 | Straumann Manufacturing, Inc. Straumann Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W Terminated |
NQA | None listed |
| Mar 23, 2018 | Straumann Manufacturing, Inc. Straumann Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115 Terminated |
NQA | None listed |
| Mar 23, 2018 | Straumann Manufacturing, Inc. Straumann Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W Terminated |
NQA | None listed |
| Mar 23, 2018 | Straumann Manufacturing, Inc. Straumann Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113 Terminated |
NQA | None listed |
| Mar 23, 2018 | Straumann Manufacturing, Inc. Straumann Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099 Terminated |
NQA | None listed |
| Mar 23, 2018 | Straumann Manufacturing, Inc. Straumann Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W Terminated |
NQA | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.