The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Beautifil Flow Plus X.
| Device ID | K172530 |
| 510k Number | K172530 |
| Device Name: | BEAUTIFIL Flow Plus X |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Shofu Dental Corporation 1225 Stone Drive San Marcos, CA 92078 |
| Contact | Mauro Malzyner |
| Correspondent | Mauro Malzyner 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 | 2017-08-21 |
| Decision Date | 2017-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E235CVPK0 | K172530 | 000 |
| E235Y24210 | K172530 | 000 |
| E235Y24220 | K172530 | 000 |
| E235Y24230 | K172530 | 000 |
| E235Y24240 | K172530 | 000 |
| E235Y24250 | K172530 | 000 |
| E235Y24260 | K172530 | 000 |
| E235Y24270 | K172530 | 000 |
| E235Y24280 | K172530 | 000 |
| E235Y24290 | K172530 | 000 |
| E235Y24320 | K172530 | 000 |
| E235Y24330 | K172530 | 000 |
| E235Y24340 | K172530 | 000 |
| E235Y24350 | K172530 | 000 |
| E235Y24360 | K172530 | 000 |
| E235Y24200 | K172530 | 000 |
| E235Y24150 | K172530 | 000 |
| E235Y24000 | K172530 | 000 |
| E235Y24010 | K172530 | 000 |
| E235Y24020 | K172530 | 000 |
| E235Y24030 | K172530 | 000 |
| E235Y24040 | K172530 | 000 |
| E235Y24050 | K172530 | 000 |
| E235Y24060 | K172530 | 000 |
| E235Y24070 | K172530 | 000 |
| E235Y24080 | K172530 | 000 |
| E235Y24090 | K172530 | 000 |
| E235Y24100 | K172530 | 000 |
| E235Y24110 | K172530 | 000 |
| E235Y24120 | K172530 | 000 |
| E235Y24140 | K172530 | 000 |
| E235Y24400 | K172530 | 000 |
| E235Y24500 | K172530 | 000 |
| E235Y24370 | K172530 | 000 |
| E235YN23210 | K172530 | 000 |
| E235YN23220 | K172530 | 000 |
| E235YN23230 | K172530 | 000 |
| E235YN23240 | K172530 | 000 |
| E235YN23250 | K172530 | 000 |
| E235YN23260 | K172530 | 000 |
| E235YN23270 | K172530 | 000 |
| E235YN23280 | K172530 | 000 |
| E235YN23290 | K172530 | 000 |
| E235YN23320 | K172530 | 000 |
| E235YN23330 | K172530 | 000 |
| E235YN23340 | K172530 | 000 |
| E235YN23350 | K172530 | 000 |
| E235YN23360 | K172530 | 000 |
| E235YN23200 | K172530 | 000 |
| E235YN23150 | K172530 | 000 |
| E235YN23000 | K172530 | 000 |
| E235YN23010 | K172530 | 000 |
| E235YN23020 | K172530 | 000 |
| E235YN23030 | K172530 | 000 |
| E235YN23040 | K172530 | 000 |
| E235YN23050 | K172530 | 000 |
| E235YN23060 | K172530 | 000 |
| E235YN23070 | K172530 | 000 |
| E235YN23080 | K172530 | 000 |
| E235YN23090 | K172530 | 000 |
| E235YN23100 | K172530 | 000 |
| E235YN23110 | K172530 | 000 |
| E235YN23120 | K172530 | 000 |
| E235YN23140 | K172530 | 000 |
| E235YN23370 | K172530 | 000 |