The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Beautifil Ii Ls.
| Device ID | K160596 |
| 510k Number | K160596 |
| Device Name: | BEAUTIFIL II LS |
| 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 | 2016-03-02 |
| Decision Date | 2016-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E235BIILSK30 | K160596 | 000 |
| E235Y22800 | K160596 | 000 |
| E235Y22790 | K160596 | 000 |
| E235Y22780 | K160596 | 000 |
| E235Y22770 | K160596 | 000 |
| E235Y22760 | K160596 | 000 |
| E235Y22750 | K160596 | 000 |
| E235Y22740 | K160596 | 000 |
| E235Y22730 | K160596 | 000 |
| E235Y22720 | K160596 | 000 |
| E235Y22710 | K160596 | 000 |
| E235Y22700 | K160596 | 000 |
| E235BIILSK50 | K160596 | 000 |
| E235BIILSK40 | K160596 | 000 |
| E235BIILSK20 | K160596 | 000 |
| E235Y22810 | K160596 | 000 |
| E235Y22820 | K160596 | 000 |
| E235Y22830 | K160596 | 000 |
| E235Y22970 | K160596 | 000 |
| E235Y22960 | K160596 | 000 |
| E235Y22950 | K160596 | 000 |
| E235Y22940 | K160596 | 000 |
| E235Y22930 | K160596 | 000 |
| E235Y22920 | K160596 | 000 |
| E235Y22910 | K160596 | 000 |
| E235Y22900 | K160596 | 000 |
| E235Y22890 | K160596 | 000 |
| E235Y22880 | K160596 | 000 |
| E235Y22870 | K160596 | 000 |
| E235Y22860 | K160596 | 000 |
| E235Y22850 | K160596 | 000 |
| E235Y22840 | K160596 | 000 |
| E235BIILSK10 | K160596 | 000 |