The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Beautifil Flow.
| Device ID | K051818 |
| 510k Number | K051818 |
| Device Name: | BEAUTIFIL FLOW |
| 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 | Yes |
| Date Received | 2005-07-05 |
| Decision Date | 2005-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23514820 | K051818 | 000 |
| E23514310 | K051818 | 000 |
| E23514320 | K051818 | 000 |
| E23514330 | K051818 | 000 |
| E23514340 | K051818 | 000 |
| E23514350 | K051818 | 000 |
| E23514490 | K051818 | 000 |
| E23514510 | K051818 | 000 |
| E23514610 | K051818 | 000 |
| E23514620 | K051818 | 000 |
| E23514630 | K051818 | 000 |
| E23514640 | K051818 | 000 |
| E23514650 | K051818 | 000 |
| E23514790 | K051818 | 000 |
| E23514840 | K051818 | 000 |