The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer One-piece Implant, 4.7mm, Straight, Models Zop47s10, Zop47s11, Zop47s13, Zop47s16.
| Device ID | K062281 |
| 510k Number | K062281 |
| Device Name: | ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16 |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Erin L Mcvey |
| Correspondent | Erin L Mcvey ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-07 |
| Decision Date | 2006-09-05 |
| Summary: | summary |