The following data is part of a premarket notification filed by Steri-oss, Inc. with the FDA for Steri-oss Threaded Tps Hex Series Implant.
| Device ID | K925555 |
| 510k Number | K925555 |
| Device Name: | STERI-OSS THREADED TPS HEX SERIES IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STERI-OSS, INC. 901 EAST CERRITOS AVE. Anaheim, CA 92805 |
| Contact | Don Kennard |
| Correspondent | Don Kennard STERI-OSS, INC. 901 EAST CERRITOS AVE. Anaheim, CA 92805 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-03 |
| Decision Date | 1994-09-19 |