The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Biohorizons Single-stage Implant.
| Device ID | K053152 |
| 510k Number | K053152 |
| Device Name: | BIOHORIZONS SINGLE-STAGE IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| 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 | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-10 |
| Decision Date | 2005-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236008246 | K053152 | 000 |
| 00847236007386 | K053152 | 000 |
| 00847236007492 | K053152 | 000 |
| 00847236007508 | K053152 | 000 |
| 00847236007614 | K053152 | 000 |
| 00847236007621 | K053152 | 000 |
| 00847236008048 | K053152 | 000 |
| 00847236008055 | K053152 | 000 |
| 00847236008062 | K053152 | 000 |
| 00847236008130 | K053152 | 000 |
| 00847236008147 | K053152 | 000 |
| 00847236008154 | K053152 | 000 |
| 00847236008222 | K053152 | 000 |
| 00847236008239 | K053152 | 000 |
| 00847236007379 | K053152 | 000 |