The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Fluroshield(tm) Visible Light Cure Pit & Fissure.
| Device ID | K896341 |
| 510k Number | K896341 |
| Device Name: | FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Contact | Jeffery Lehn |
| Correspondent | Jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-03 |
| Decision Date | 1990-04-23 |