The following data is part of a premarket notification filed by Medental Intl. with the FDA for Medental Chemical Curing Sealant Pit & Fissure Tinted.
| Device ID | K973541 |
| 510k Number | K973541 |
| Device Name: | MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | MEDENTAL INTL. 1246 CLEAR CREEK RD. Evergreen, CO 80434 |
| Contact | Debra Gillaspy |
| Correspondent | Debra Gillaspy MEDENTAL INTL. 1246 CLEAR CREEK RD. Evergreen, CO 80434 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-18 |
| Decision Date | 1997-11-25 |