The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Tapered Screw-vent T Implant.
| Device ID | K101977 |
| 510k Number | K101977 |
| Device Name: | TAPERED SCREW-VENT T IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Jeremy Markovich |
| Correspondent | Jeremy Markovich 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 | 2010-07-14 |
| Decision Date | 2010-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024019966 | K101977 | 000 |
| 00889024019836 | K101977 | 000 |
| 00889024019843 | K101977 | 000 |
| 00889024019850 | K101977 | 000 |
| 00889024019867 | K101977 | 000 |
| 00889024019928 | K101977 | 000 |
| 00889024019935 | K101977 | 000 |
| 00889024019942 | K101977 | 000 |
| 00889024019959 | K101977 | 000 |
| 00889024019829 | K101977 | 000 |