The following data is part of a premarket notification filed by Tav Medical Ltd. with the FDA for Tav Medical Dental Implants System.
Device ID | K170131 |
510k Number | K170131 |
Device Name: | TAV Medical Dental Implants System |
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 | 2017-01-17 |
Decision Date | 2018-02-10 |
Summary: | summary |