The following data is part of a premarket notification filed by Fvtnks with the FDA for Wiley/esposito Dental Guard.
| Device ID | K935713 |
| 510k Number | K935713 |
| Device Name: | WILEY/ESPOSITO DENTAL GUARD |
| Classification | Protector, Dental |
| Applicant | FVTNKS 10415 BRIGGS CT. Indianapolis, IN 46256 -9719 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden FVTNKS 10415 BRIGGS CT. Indianapolis, IN 46256 -9719 |
| Product Code | BRW |
| CFR Regulation Number | 868.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-30 |
| Decision Date | 1994-01-05 |