The following data is part of a premarket notification filed by Zimmer Dental, Inc. with the FDA for Zimmer Patient-specific Abutment, Internal Hex, Titanium.
| Device ID | K143505 |
| 510k Number | K143505 |
| Device Name: | Zimmer Patient-Specific Abutment, Internal Hex, Titanium |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Zimmer Dental, Inc. 1900 Aston Ave. Carldsbad, CA 92008 |
| Contact | Christina Boydston |
| Correspondent | Christina Boydston Zimmer Dental, Inc. 1900 Aston Ave. Carldsbad, CA 92008 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-10 |
| Decision Date | 2015-06-25 |
| Summary: | summary |