The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer Contour Restorative System.
| Device ID | K061043 |
| 510k Number | K061043 |
| Device Name: | ZIMMER CONTOUR RESTORATIVE SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Erin L Mcvey |
| Correspondent | Erin L Mcvey 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 | 2006-04-14 |
| Decision Date | 2006-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024021167 | K061043 | 000 |
| 00889024020962 | K061043 | 000 |
| 00889024020979 | K061043 | 000 |
| 00889024020986 | K061043 | 000 |
| 00889024020993 | K061043 | 000 |
| 00889024021006 | K061043 | 000 |
| 00889024021013 | K061043 | 000 |
| 00889024021020 | K061043 | 000 |
| 00889024021112 | K061043 | 000 |
| 00889024021129 | K061043 | 000 |
| 00889024021136 | K061043 | 000 |
| 00889024021143 | K061043 | 000 |
| 00889024021150 | K061043 | 000 |
| 00889024020955 | K061043 | 000 |