The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer Dental One-piece Implant.
| Device ID | K052997 |
| 510k Number | K052997 |
| Device Name: | ZIMMER DENTAL ONE-PIECE IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| 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 | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-25 |
| Decision Date | 2006-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024021327 | K052997 | 000 |
| 00889024021310 | K052997 | 000 |
| 00889024021303 | K052997 | 000 |
| 00889024021280 | K052997 | 000 |
| 00889024021273 | K052997 | 000 |
| 00889024021266 | K052997 | 000 |