The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer Dental Tapered Screw-vent M Implant.
| Device ID | K111889 |
| 510k Number | K111889 |
| Device Name: | ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Melissa Burbage |
| Correspondent | Melissa Burbage 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 | 2011-07-01 |
| Decision Date | 2011-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024019768 | K111889 | 000 |
| 00889024019638 | K111889 | 000 |
| 00889024019645 | K111889 | 000 |
| 00889024019652 | K111889 | 000 |
| 00889024019669 | K111889 | 000 |
| 00889024019720 | K111889 | 000 |
| 00889024019737 | K111889 | 000 |
| 00889024019744 | K111889 | 000 |
| 00889024019751 | K111889 | 000 |
| 00889024019621 | K111889 | 000 |