The following data is part of a premarket notification filed by T.a.g. Medical Products Corporation, Ltd with the FDA for T.a.g. Dental Implant System.
Device ID | K143326 |
510k Number | K143326 |
Device Name: | T.A.G. Dental Implant System |
Classification | Implant, Endosseous, Root-form |
Applicant | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD D. N. ASHRAT Kibbutz Gatton, IL 25130 |
Contact | Erez Adiv |
Correspondent | George J Hattub MedicSense, USA 291 Hillside Avenue Somerset, MA 02726 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-20 |
Decision Date | 2015-05-14 |
Summary: | summary |