The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Beautifil E Posterior, Beautifil Bulk.
| Device ID | K132748 |
| 510k Number | K132748 |
| Device Name: | BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK |
| 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 | 2013-09-03 |
| Decision Date | 2013-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23520350 | K132748 | 000 |
| E23520340 | K132748 | 000 |
| E23520330 | K132748 | 000 |
| E23520320 | K132748 | 000 |