The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Biohorizons Tapered Short Implants.
| Device ID | K172576 |
| 510k Number | K172576 |
| Device Name: | BioHorizons Tapered Short Implants |
| Classification | Implant, Endosseous, Root-form |
| 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 | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-28 |
| Decision Date | 2017-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236000684 | K172576 | 000 |
| 00847236000677 | K172576 | 000 |
| 00847236000660 | K172576 | 000 |
| 00847236000653 | K172576 | 000 |