The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Shofu Enamel Conditioner.
| Device ID | K160086 |
| 510k Number | K160086 |
| Device Name: | SHOFU Enamel Conditioner |
| 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 | 2016-01-15 |
| Decision Date | 2016-07-21 |