The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer Zfx Titanium Abutment For Biomet 3i Certain Implant System.
| Device ID | K141544 |
| 510k Number | K141544 |
| Device Name: | ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Christina Boydston |
| Correspondent | Christina Boydston ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-10 |
| Decision Date | 2014-10-22 |
| Summary: | summary |