The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer Dental Tapered Swissplus Implants.
| Device ID | K082639 |
| 510k Number | K082639 |
| Device Name: | ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-10 |
| Decision Date | 2008-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024017429 | K082639 | 000 |