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 |