The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Beautifil Ii Enamel.
| Device ID | K151699 |
| 510k Number | K151699 |
| Device Name: | BEAUTIFIL II Enamel |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SHOFU DENTAL CORPORATION 1225 STONE DRIVE San Marcos, CA 92078 |
| Contact | Mauro Malyzyner |
| Correspondent | Mauro Malyzyner SHOFU DENTAL CORPORATION 1225 STONE DRIVE San Marcos, CA 92078 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-24 |
| Decision Date | 2015-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E235Y22530 | K151699 | 000 |
| E235Y22520 | K151699 | 000 |
| E235Y22510 | K151699 | 000 |
| E235Y22500 | K151699 | 000 |