Barrier, Synthetic, Intraoral
Regulation 872.3930
0510(k)s in 12 months (31 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in NPK
| Company | 510(k)s | Recalls |
|---|---|---|
| W. L. Gore & Associates, Inc. | 5 | 0 |
| American Custom Medical, Inc. | 3 | 0 |
| Atrix Laboratories, Inc. | 2 | 0 |
| Imtec Corp. | 2 | 0 |
| Inion , Ltd. | 1 | 1 |
| Osteogenics Biomedical, Inc. | 2 | 0 |
| Porex Surgical, Inc. | 2 | 0 |
| B&Medi Co., Ltd. | 1 | 0 |
| Cowellmedi Co., Ltd. | 1 | 0 |
| Criteria Industria E Comercio DE Produtos Medicinais | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2017 | Inion Ltd. Inion GRT Tack, drill bit and tack appl., 4x, Sterile.
Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue Terminated |
NPK | K033074 |
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