The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Biohorizons Dental Implant System.
| Device ID | K960026 |
| 510k Number | K960026 |
| Device Name: | BIOHORIZONS DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOHORIZONS IMPLANT SYSTEMS, INC. 2129 MONTGOMERY WAY Birmingham, AL 35209 |
| Contact | R. Steven Boggan |
| Correspondent | R. Steven Boggan BIOHORIZONS IMPLANT SYSTEMS, INC. 2129 MONTGOMERY WAY Birmingham, AL 35209 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-02 |
| Decision Date | 1996-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236005726 | K960026 | 000 |
| 00847236002367 | K960026 | 000 |
| 00847236002374 | K960026 | 000 |
| 00847236002381 | K960026 | 000 |
| 00847236002398 | K960026 | 000 |
| 00847236002404 | K960026 | 000 |
| 00847236001940 | K960026 | 000 |
| 00847236001957 | K960026 | 000 |
| 00847236001971 | K960026 | 000 |
| 00847236002336 | K960026 | 000 |
| 00847236002329 | K960026 | 000 |
| 00847236000257 | K960026 | 000 |
| 00847236002114 | K960026 | 000 |
| 00847236002121 | K960026 | 000 |
| 00847236002138 | K960026 | 000 |
| 00847236002145 | K960026 | 000 |
| 00847236002268 | K960026 | 000 |
| 00847236002282 | K960026 | 000 |
| 00847236002312 | K960026 | 000 |
| 00847236001988 | K960026 | 000 |
| 00847236001995 | K960026 | 000 |
| 00847236002671 | K960026 | 000 |
| 00847236002688 | K960026 | 000 |
| 00847236002695 | K960026 | 000 |
| 00847236002701 | K960026 | 000 |
| 00847236002718 | K960026 | 000 |
| 00847236002725 | K960026 | 000 |
| 00847236002732 | K960026 | 000 |
| 00847236002749 | K960026 | 000 |
| 00847236002350 | K960026 | 000 |
| 00847236002343 | K960026 | 000 |
| 00847236002008 | K960026 | 000 |
| 00847236002060 | K960026 | 000 |
| 00847236002077 | K960026 | 000 |
| 00847236002084 | K960026 | 000 |
| 00847236002091 | K960026 | 000 |
| 00847236002107 | K960026 | 000 |
| 00847236002299 | K960026 | 000 |
| 00847236002305 | K960026 | 000 |
| 00847236000240 | K960026 | 000 |