The following data is part of a premarket notification filed by B&w Srl with the FDA for B&w Dental Implant System.
| Device ID | K120875 |
| 510k Number | K120875 |
| Device Name: | B&W DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | B&W SRL CORRIENTES 3859 Buenos Aires, AR Ar |
| Contact | Priya Bhutani |
| Correspondent | Priya Bhutani B&W SRL CORRIENTES 3859 Buenos Aires, AR Ar |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-22 |
| Decision Date | 2012-09-07 |