The following data is part of a premarket notification filed by Steri-oss, Inc. with the FDA for Miniball Abutment.
| Device ID | K930155 |
| 510k Number | K930155 |
| Device Name: | MINIBALL ABUTMENT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STERI-OSS, INC. 901 EAST CERRITOS AVE. Anaheim, CA 92805 |
| Contact | Paul Gasser |
| Correspondent | Paul Gasser 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 | 1993-01-13 |
| Decision Date | 1994-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747012750 | K930155 | 000 |
| 07332747000375 | K930155 | 000 |
| 07332747000382 | K930155 | 000 |
| 07332747000399 | K930155 | 000 |
| 07332747000405 | K930155 | 000 |
| 07332747000412 | K930155 | 000 |
| 07332747000429 | K930155 | 000 |
| 07332747000436 | K930155 | 000 |
| 07332747000443 | K930155 | 000 |
| 07332747012743 | K930155 | 000 |
| 07332747000368 | K930155 | 000 |