The following data is part of a premarket notification filed by Sic Invent Ag with the FDA for Sic Pro.
Device ID | K040757 |
510k Number | K040757 |
Device Name: | SIC PRO |
Classification | Implant, Endosseous, Root-form |
Applicant | SIC INVENT AG CH-4055 Basel, CH |
Contact | Georg Schilli |
Correspondent | Georg Schilli SIC INVENT AG CH-4055 Basel, CH |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-03-25 |
Decision Date | 2005-04-13 |
Summary: | summary |