The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer One Piece Implant, 3.0mm Angled, Models Zop30a10, Zop30a11 And Zop30a13.
| Device ID | K071235 |
| 510k Number | K071235 |
| Device Name: | ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | William Fisher |
| Correspondent | William Fisher 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 | 2007-05-03 |
| Decision Date | 2007-05-30 |
| Summary: | summary |