The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Biohorizons Cad/cam Abutments.
| Device ID | K151621 |
| 510k Number | K151621 |
| Device Name: | BioHorizons CAD/CAM Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | BIOHORIZONS IMPLANT SYSTEMS, INC. 2300 RIVERCHASE CENTER Birmingham, AL 35244 |
| Contact | Michael Davis |
| Correspondent | Michael Davis BIOHORIZONS IMPLANT SYSTEMS, INC. 2300 RIVERCHASE CENTER Birmingham, AL 35244 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-16 |
| Decision Date | 2016-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236012274 | K151621 | 000 |
| 00847236021696 | K151621 | 000 |
| 00847236021702 | K151621 | 000 |
| 00847236021719 | K151621 | 000 |
| 00847236017422 | K151621 | 000 |
| 00847236017439 | K151621 | 000 |
| 00847236012076 | K151621 | 000 |
| 00847236012090 | K151621 | 000 |
| 00847236012113 | K151621 | 000 |
| 00847236012137 | K151621 | 000 |
| 00847236012243 | K151621 | 000 |
| 00847236012250 | K151621 | 000 |
| 00847236012267 | K151621 | 000 |
| 00847236021689 | K151621 | 000 |