The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer Contour Provisional Coping.
| Device ID | K113092 |
| 510k Number | K113092 |
| Device Name: | ZIMMER CONTOUR PROVISIONAL COPING |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Jeremy Markovich |
| Correspondent | Jeremy Markovich 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 | 2011-10-19 |
| Decision Date | 2012-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024020498 | K113092 | 000 |
| 00889024016965 | K113092 | 000 |
| 00889024016972 | K113092 | 000 |
| 00889024020344 | K113092 | 000 |
| 00889024020351 | K113092 | 000 |
| 00889024020368 | K113092 | 000 |
| 00889024020375 | K113092 | 000 |
| 00889024020382 | K113092 | 000 |
| 00889024020399 | K113092 | 000 |
| 00889024020405 | K113092 | 000 |
| 00889024020412 | K113092 | 000 |
| 00889024020429 | K113092 | 000 |
| 00889024020436 | K113092 | 000 |
| 00889024020443 | K113092 | 000 |
| 00889024020450 | K113092 | 000 |
| 00889024020467 | K113092 | 000 |
| 00889024020474 | K113092 | 000 |
| 00889024020481 | K113092 | 000 |
| 00889024016958 | K113092 | 000 |