The following data is part of a premarket notification filed by Prime Dental Manufacturing, Inc. with the FDA for Prime-dent Visible Light Cure Pit & Fissure Sealant.
| Device ID | K012761 |
| 510k Number | K012761 |
| Device Name: | PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | PRIME DENTAL MANUFACTURING, INC. 3735 WEST BELMONT AVE. Chicago, IL 60618 |
| Contact | Rolando Marasigan |
| Correspondent | Rolando Marasigan PRIME DENTAL MANUFACTURING, INC. 3735 WEST BELMONT AVE. Chicago, IL 60618 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-17 |
| Decision Date | 2001-11-01 |