The following data is part of a premarket notification filed by Bego Implant Systems Gmbh & Co. Kg with the FDA for Bego Semados S-line.
Device ID | K090716 |
510k Number | K090716 |
Device Name: | BEGO SEMADOS S-LINE |
Classification | Implant, Endosseous, Root-form |
Applicant | BEGO IMPLANT SYSTEMS GMBH & CO. KG WILHELM HERBST STRASSE 1 Bremen, DE 28359 |
Contact | Martin Ellerhorst |
Correspondent | Martin Ellerhorst BEGO IMPLANT SYSTEMS GMBH & CO. KG WILHELM HERBST STRASSE 1 Bremen, DE 28359 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-03-18 |
Decision Date | 2009-10-06 |
Summary: | summary |