The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Beautifil Bulk Flowable.
| Device ID | K132141 |
| 510k Number | K132141 |
| Device Name: | BEAUTIFIL BULK FLOWABLE |
| Classification | Material, Tooth Shade, Resin |
| 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-11 |
| Decision Date | 2013-10-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23520690 | K132141 | 000 |
| E23520290 | K132141 | 000 |
| E23520300 | K132141 | 000 |
| E23520310 | K132141 | 000 |
| E23520620 | K132141 | 000 |
| E23520630 | K132141 | 000 |
| E23520640 | K132141 | 000 |
| E23520650 | K132141 | 000 |
| E23520660 | K132141 | 000 |
| E23520670 | K132141 | 000 |
| E23520680 | K132141 | 000 |
| E23520280 | K132141 | 000 |