The following data is part of a premarket notification filed by Sic Invent Ag with the FDA for Sictapered & Sicvantage Tapered.
Device ID | K210489 |
510k Number | K210489 |
Device Name: | SICtapered & SICvantage Tapered |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-02-19 |
Decision Date | 2022-03-17 |