The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer Zfx Titanium Abutment, Base Abutment And Abutment Blank For Nobelactive Implant System.
| Device ID | K134045 |
| 510k Number | K134045 |
| Device Name: | ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Julie Lamothe |
| Correspondent | Julie Lamothe 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 | 2013-12-31 |
| Decision Date | 2014-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024344433 | K134045 | 000 |
| 00889024344426 | K134045 | 000 |
| 00889024344402 | K134045 | 000 |
| 00889024344396 | K134045 | 000 |