The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Beauticem Veneer Kit.
| Device ID | K180649 |
| 510k Number | K180649 |
| Device Name: | BeautiCem Veneer Kit |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Shofu Dental Corporation 1225 Stone Drive San Marcos, CA 92078 |
| Contact | Mauro Malzyner |
| Correspondent | Mauro Malzyner 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 | 2018-03-13 |
| Decision Date | 2018-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E235C00130 | K180649 | 000 |
| E235C00040 | K180649 | 000 |
| E235C00050 | K180649 | 000 |
| E235C00060 | K180649 | 000 |
| E235C00070 | K180649 | 000 |
| E235C00080 | K180649 | 000 |
| E235C00090 | K180649 | 000 |
| E235C00100 | K180649 | 000 |
| E235C00110 | K180649 | 000 |
| E235C00120 | K180649 | 000 |
| E235C00020 | K180649 | 000 |