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 |