The following data is part of a premarket notification filed by Collagen Corp. with the FDA for Osseodent Surgical Kit.
| Device ID | K894331 |
| 510k Number | K894331 |
| Device Name: | OSSEODENT SURGICAL KIT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | COLLAGEN CORP. 2500 FABER PLACE Palo Alto, CA 94303 |
| Contact | Cindy Domecus |
| Correspondent | Cindy Domecus COLLAGEN CORP. 2500 FABER PLACE Palo Alto, CA 94303 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-14 |
| Decision Date | 1989-10-04 |