The following data is part of a premarket notification filed by Steri-oss, Inc. with the FDA for Steri-oss Gold Attachment System.
| Device ID | K963945 |
| 510k Number | K963945 |
| Device Name: | STERI-OSS GOLD ATTACHMENT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Contact | Don Kennard |
| Correspondent | Don Kennard 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 | 1996-10-02 |
| Decision Date | 1997-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747010534 | K963945 | 000 |
| 07332747010381 | K963945 | 000 |
| 07332747010350 | K963945 | 000 |
| 17332747000013 | K963945 | 000 |