The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Protec/visible Light-cured Sealant/dental Restorat.
| Device ID | K854882 |
| 510k Number | K854882 |
| Device Name: | PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | LEE PHARMACEUTICALS 1444 SANTA ANITA P.O. BOX 3836 South El Monte, CA 91733 |
| Contact | Dian Tiegler |
| Correspondent | Dian Tiegler LEE PHARMACEUTICALS 1444 SANTA ANITA P.O. BOX 3836 South El Monte, CA 91733 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-06 |
| Decision Date | 1986-01-30 |