The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for O-ring Abutment.
| Device ID | K990277 |
| 510k Number | K990277 |
| Device Name: | O-RING ABUTMENT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243 |
| Contact | Diana M Easton |
| Correspondent | Diana M Easton BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-28 |
| Decision Date | 1999-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236002626 | K990277 | 000 |
| 00847236002619 | K990277 | 000 |
| 00847236002602 | K990277 | 000 |
| 00847236002596 | K990277 | 000 |
| 00847236002589 | K990277 | 000 |
| 00847236002572 | K990277 | 000 |
| 00847236000288 | K990277 | 000 |
| 00847236000271 | K990277 | 000 |
| 00847236000264 | K990277 | 000 |