The following data is part of a premarket notification filed by Dentsply International with the FDA for Delton Illuminating Pit And Fissure Sealing.
| Device ID | K050959 |
| 510k Number | K050959 |
| Device Name: | DELTON ILLUMINATING PIT AND FISSURE SEALING |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | DENTSPLY INTERNATIONAL 221 W. PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL 221 W. PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-18 |
| Decision Date | 2005-05-11 |
| Summary: | summary |