The following data is part of a premarket notification filed by Isotis Orthobiologics, Inc with the FDA for Ossatura Dental.
| Device ID | K042706 |
| 510k Number | K042706 |
| Device Name: | OSSATURA DENTAL |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | ISOTIS ORTHOBIOLOGICS, INC 2 GOODYEAR, SUITE B Irvine, CA 92618 |
| Contact | Paul Doner |
| Correspondent | Paul Doner ISOTIS ORTHOBIOLOGICS, INC 2 GOODYEAR, SUITE B Irvine, CA 92618 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-30 |
| Decision Date | 2004-10-20 |
| Summary: | summary |