The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer One Piece Implant, 3.7mm And 4.7mm, Models Zop37s10, 11, 13, 16; Zop37a10, 11, 13, 16; Zop47s10, 11, 13, 16; Zop4.
| Device ID | K063523 |
| 510k Number | K063523 |
| Device Name: | ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16; ZOP37A10, 11, 13, 16; ZOP47S10, 11, 13, 16; ZOP4 |
| 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 | 2006-11-22 |
| Decision Date | 2007-02-16 |