The following data is part of a premarket notification filed by Osseous Technologies Of America with the FDA for Ota Collagen Biomaterial.
| Device ID | K073685 |
| 510k Number | K073685 |
| Device Name: | OTA COLLAGEN BIOMATERIAL |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | OSSEOUS TECHNOLOGIES OF AMERICA 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | David J Collette |
| Correspondent | David J Collette OSSEOUS TECHNOLOGIES OF AMERICA 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-28 |
| Decision Date | 2008-08-29 |
| Summary: | summary |