The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer Cast-to Gold Abutments For The 3.1mmd Dental Implant System.
| Device ID | K143528 |
| 510k Number | K143528 |
| Device Name: | Zimmer Cast-to Gold Abutments For The 3.1mmD Dental Implant System |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 |
| Contact | Christina Boydston |
| Correspondent | Christina Boydston ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-12 |
| Decision Date | 2015-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024344457 | K143528 | 000 |
| 00889024344440 | K143528 | 000 |