The following data is part of a premarket notification filed by Bonafix Surgical And Dental Implants with the FDA for Bonafix Two - Dental Implant System.
| Device ID | K162853 |
| 510k Number | K162853 |
| Device Name: | Bonafix TWO - Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BONAFIX SURGICAL AND DENTAL IMPLANTS 118 W PRIVE CIR Delray Beach, FL 33445 |
| Contact | Juan Tezak |
| Correspondent | Juan Tezak BONAFIX SURGICAL AND DENTAL IMPLANTS 118 W PRIVE CIR Delray Beach, FL 33445 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-11 |
| Decision Date | 2017-07-14 |
| Summary: | summary |