The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Wundershade.
| Device ID | K852868 |
| 510k Number | K852868 |
| Device Name: | WUNDERSHADE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
| Contact | Goldstein |
| Correspondent | Goldstein HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-08 |
| Decision Date | 1985-09-27 |