The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Tapered Screw-vent T Implant, Tapered Screw-vent P Implant.
| Device ID | K101880 |
| 510k Number | K101880 |
| Device Name: | TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P 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 | 2010-07-06 |
| Decision Date | 2010-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024020030 | K101880 | 000 |
| 00889024019805 | K101880 | 000 |
| 00889024019799 | K101880 | 000 |
| 00889024019782 | K101880 | 000 |
| 00889024019775 | K101880 | 000 |
| 00889024019713 | K101880 | 000 |
| 00889024019706 | K101880 | 000 |
| 00889024019690 | K101880 | 000 |
| 00889024019683 | K101880 | 000 |
| 00889024019812 | K101880 | 000 |
| 00889024019874 | K101880 | 000 |
| 00889024020023 | K101880 | 000 |
| 00889024020016 | K101880 | 000 |
| 00889024020009 | K101880 | 000 |
| 00889024019997 | K101880 | 000 |
| 00889024019911 | K101880 | 000 |
| 00889024019904 | K101880 | 000 |
| 00889024019898 | K101880 | 000 |
| 00889024019881 | K101880 | 000 |
| 00889024019676 | K101880 | 000 |