The following data is part of a premarket notification filed by Forestadent with the FDA for Forestadent Orthodontic Bands.
| Device ID | K925028 |
| 510k Number | K925028 |
| Device Name: | FORESTADENT ORTHODONTIC BANDS |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | FORESTADENT 7530 PFORZHEIM WESTLICHE 151 POSTFACH 660 Germany, DE |
| Contact | Forster Gmb |
| Correspondent | Forster Gmb FORESTADENT 7530 PFORZHEIM WESTLICHE 151 POSTFACH 660 Germany, DE |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-02 |
| Decision Date | 1994-01-26 |