The following data is part of a premarket notification filed by Sic Invent Ag with the FDA for Sicace Dental Implant System And Sic Angled Abutments.
Device ID | K061500 |
510k Number | K061500 |
Device Name: | SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS |
Classification | Implant, Endosseous, Root-form |
Applicant | SIC INVENT AG GRIESWEG 47 Muehlheim, DE 78570 |
Contact | Franz Menean |
Correspondent | Franz Menean SIC INVENT AG GRIESWEG 47 Muehlheim, DE 78570 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-05-31 |
Decision Date | 2006-08-08 |
Summary: | summary |