The following data is part of a premarket notification filed by Mission White Dental, Inc. with the FDA for Oralin Tlc Light Cured Pit And Fissure Sealant.
| Device ID | K875091 |
| 510k Number | K875091 |
| Device Name: | ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | MISSION WHITE DENTAL, INC. 31 PARK RD. Tinton Falls, NJ 07724 |
| Contact | Joseph J Butler |
| Correspondent | Joseph J Butler MISSION WHITE DENTAL, INC. 31 PARK RD. Tinton Falls, NJ 07724 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-10 |
| Decision Date | 1988-02-29 |