The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Beautisealant.
Device ID | K111782 |
510k Number | K111782 |
Device Name: | BEAUTISEALANT |
Classification | Sealant, Pit And Fissure, And Conditioner |
Applicant | SHOFU DENTAL CORPORATION 1225 STONE DRIVE San Marcos, CA 92078 |
Contact | David P Morais |
Correspondent | David P Morais SHOFU DENTAL CORPORATION 1225 STONE DRIVE San Marcos, CA 92078 |
Product Code | EBC |
CFR Regulation Number | 872.3765 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-24 |
Decision Date | 2011-09-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
E23518000 | K111782 | 000 |
E23517990 | K111782 | 000 |
E23517980 | K111782 | 000 |
E23517940 | K111782 | 000 |