The following data is part of a premarket notification filed by Forestadent Bernhard Forster Gmbh with the FDA for Forestadent Brackets.
Device ID | K924971 |
510k Number | K924971 |
Device Name: | FORESTADENT BRACKETS |
Classification | Bracket, Metal, Orthodontic |
Applicant | FORESTADENT BERNHARD FORSTER GMBH 7530 PFORZHEIM WESTLICHE 151 POSTFACH 660 D-7530 Pforzheim Germany, GR |
Product Code | EJF |
CFR Regulation Number | 872.5410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-30 |
Decision Date | 1993-05-27 |