The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Biohorizons Ceramic Abutment.
| Device ID | K061567 |
| 510k Number | K061567 |
| Device Name: | BIOHORIZONS CERAMIC ABUTMENT |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243 |
| Contact | Winston Greer |
| Correspondent | Winston Greer BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-06 |
| Decision Date | 2006-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236010959 | K061567 | 000 |
| 00847236010942 | K061567 | 000 |