The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer Zfx Abutment For Nobel Replace Implant System.
| Device ID | K120873 |
| 510k Number | K120873 |
| Device Name: | ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Melissa Burbage |
| Correspondent | Melissa Burbage 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 | 2012-03-22 |
| Decision Date | 2012-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024020696 | K120873 | 000 |
| 00889024020689 | K120873 | 000 |
| 00889024020535 | K120873 | 000 |
| 00889024020528 | K120873 | 000 |
| 00889024020511 | K120873 | 000 |
| 00889024020504 | K120873 | 000 |