The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Beautifil.
| Device ID | K010914 |
| 510k Number | K010914 |
| Device Name: | BEAUTIFIL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SHOFU DENTAL CORP. 4025 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Contact | Cindky Rhoades |
| Correspondent | Cindky Rhoades SHOFU DENTAL CORP. 4025 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-27 |
| Decision Date | 2001-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23513890 | K010914 | 000 |
| E23513710 | K010914 | 000 |
| E23513720 | K010914 | 000 |
| E23513730 | K010914 | 000 |
| E23513740 | K010914 | 000 |
| E23513750 | K010914 | 000 |
| E23513770 | K010914 | 000 |
| E23513780 | K010914 | 000 |
| E23513790 | K010914 | 000 |
| E23513830 | K010914 | 000 |
| E23513840 | K010914 | 000 |
| E23513870 | K010914 | 000 |
| E23513880 | K010914 | 000 |
| E23513690 | K010914 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BEAUTIFIL 76306668 2563704 Live/Registered |
SHOFU, INC. 2001-08-30 |