The following data is part of a premarket notification filed by Steri-oss, Inc. with the FDA for Steri-oss Tiodized Screw.
| Device ID | K964739 |
| 510k Number | K964739 |
| Device Name: | STERI-OSS TIODIZED SCREW |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Contact | Jeff Hausheer, Ph.d. |
| Correspondent | Jeff Hausheer, Ph.d. STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-26 |
| Decision Date | 1997-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747012446 | K964739 | 000 |
| 07332747003970 | K964739 | 000 |
| 07332747003987 | K964739 | 000 |
| 07332747003994 | K964739 | 000 |
| 07332747004007 | K964739 | 000 |
| 07332747004014 | K964739 | 000 |
| 07332747004021 | K964739 | 000 |
| 07332747004045 | K964739 | 000 |
| 07332747004052 | K964739 | 000 |
| 07332747004069 | K964739 | 000 |
| 07332747012293 | K964739 | 000 |
| 07332747012309 | K964739 | 000 |
| 07332747012439 | K964739 | 000 |
| 07332747000276 | K964739 | 000 |