The following data is part of a premarket notification filed by Tav Medical Ltd. with the FDA for W Zirconia Implants.
| Device ID | K192053 |
| 510k Number | K192053 |
| Device Name: | W Zirconia Implants |
| Classification | Implant, Endosseous, Root-form |
| Applicant | TAV Medical Ltd. Dora Industrial Park, P.O. Box 88 Shlomi, IL 2283202 |
| Contact | Revital Shabtai |
| Correspondent | Revital Shabtai TAV Medical Ltd. Dora Industrial Park, P.O. Box 88 Shlomi, IL 2283202 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-31 |
| Decision Date | 2019-10-29 |
| Summary: | summary |