The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Biohorizons Cad/cam Bars.
| Device ID | K180998 |
| 510k Number | K180998 |
| Device Name: | BioHorizons CAD/CAM Bars |
| 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 | 2018-04-16 |
| Decision Date | 2018-09-28 |
| Summary: | summary |