The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Beautifil Opaquer.
| Device ID | K080068 |
| 510k Number | K080068 |
| Device Name: | BEAUTIFIL OPAQUER |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SHOFU DENTAL CORP. 1225 STONE DR. San Marcos, CA 92078 |
| Contact | David P Morais |
| Correspondent | David P Morais SHOFU DENTAL CORP. 1225 STONE DR. 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 | 2008-01-10 |
| Decision Date | 2008-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23513640 | K080068 | 000 |
| E23513630 | K080068 | 000 |