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 |