The following data is part of a premarket notification filed by Sic Invent Ag with the FDA for Sic Invent Dental Implant Systems.
Device ID | K173207 |
510k Number | K173207 |
Device Name: | SIC Invent Dental Implant Systems |
Classification | Implant, Endosseous, Root-form |
Applicant | SIC Invent AG Birmannsgasse 3 Basel, CH Ch-4055 |
Contact | Cretia Arlene Mcnett |
Correspondent | Cretia Arlene Mcnett SIC Invent AG Birmannsgasse 3 Basel, CH Ch-4055 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-02 |
Decision Date | 2018-04-05 |