The following data is part of a premarket notification filed by Forestadent Bernhard Forster Gmbh with the FDA for Facebow.
| Device ID | K925240 |
| 510k Number | K925240 |
| Device Name: | FACEBOW |
| Classification | Headgear, Extraoral, Orthodontic |
| Applicant | FORESTADENT BERNHARD FORSTER GMBH 7530 PFORZHEIM WESTLICHE 151 POSTFACH 660 D-7530 Pforzheim Germany, GR |
| Product Code | DZB |
| CFR Regulation Number | 872.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-16 |
| Decision Date | 1993-06-18 |