The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer Patient-specific Ceramic Abutment.
| Device ID | K080164 |
| 510k Number | K080164 |
| Device Name: | ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Erin Mcvey |
| Correspondent | Erin 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 | 2008-01-23 |
| Decision Date | 2008-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844868038085 | K080164 | 000 |
| 00844868038078 | K080164 | 000 |
| 00844868038061 | K080164 | 000 |
| 00844868038054 | K080164 | 000 |
| 00844868038047 | K080164 | 000 |
| 00844868038030 | K080164 | 000 |
| 00844868038023 | K080164 | 000 |
| 00844868038016 | K080164 | 000 |