The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer Contour Ceramic Abutment, Models Zra341s, Zra342s, Kra451s, Zra452s.
| Device ID | K061847 |
| 510k Number | K061847 |
| Device Name: | ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | William Fisher |
| Correspondent | William Fisher 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 | 2006-06-30 |
| Decision Date | 2006-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024021532 | K061847 | 000 |
| 00889024021525 | K061847 | 000 |
| 00889024021495 | K061847 | 000 |
| 00889024021488 | K061847 | 000 |