The following data is part of a premarket notification filed by Forestadent Bernhard Forster Gmbh with the FDA for Bernhard-forster Gmbh Orthodontic Ceramic Brackets.
Device ID | K090933 |
510k Number | K090933 |
Device Name: | BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS |
Classification | Bracket, Ceramic, Orthodontic |
Applicant | FORESTADENT BERNHARD FORSTER GMBH WESTLICHE KARL-FRIEDRICH STR 151 Pforzheim, Baden Wurtemberg, DE D-75172 |
Contact | Michael Fieb |
Correspondent | Michael Fieb FORESTADENT BERNHARD FORSTER GMBH WESTLICHE KARL-FRIEDRICH STR 151 Pforzheim, Baden Wurtemberg, DE D-75172 |
Product Code | NJM |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-02 |
Decision Date | 2009-06-05 |
Summary: | summary |