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 |