The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Ceramage Up.
| Device ID | K162261 |
| 510k Number | K162261 |
| Device Name: | CERAMAGE UP |
| 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 | 2016-08-11 |
| Decision Date | 2017-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23523050 | K162261 | 000 |
| E23523270 | K162261 | 000 |
| E23523310 | K162261 | 000 |
| E23523320 | K162261 | 000 |
| E23523330 | K162261 | 000 |
| E23523340 | K162261 | 000 |
| E23523350 | K162261 | 000 |
| E23523360 | K162261 | 000 |
| E23523370 | K162261 | 000 |
| E23523380 | K162261 | 000 |
| E23523390 | K162261 | 000 |
| E23523400 | K162261 | 000 |
| E23523410 | K162261 | 000 |
| E23523420 | K162261 | 000 |
| E23523430 | K162261 | 000 |
| E23523440 | K162261 | 000 |
| E23523260 | K162261 | 000 |
| E23523250 | K162261 | 000 |
| E23523060 | K162261 | 000 |
| E23523110 | K162261 | 000 |
| E23523120 | K162261 | 000 |
| E23523130 | K162261 | 000 |
| E23523140 | K162261 | 000 |
| E23523150 | K162261 | 000 |
| E23523160 | K162261 | 000 |
| E23523170 | K162261 | 000 |
| E23523180 | K162261 | 000 |
| E23523190 | K162261 | 000 |
| E23523200 | K162261 | 000 |
| E23523210 | K162261 | 000 |
| E23523220 | K162261 | 000 |
| E23523230 | K162261 | 000 |
| E23523240 | K162261 | 000 |
| E23523450 | K162261 | 000 |
| E23523460 | K162261 | 000 |
| E23523470 | K162261 | 000 |
| E23523690 | K162261 | 000 |
| E23523710 | K162261 | 000 |
| E23523720 | K162261 | 000 |
| E23523730 | K162261 | 000 |
| E23523740 | K162261 | 000 |
| E23523750 | K162261 | 000 |
| E23523810 | K162261 | 000 |
| E23523820 | K162261 | 000 |
| E23523830 | K162261 | 000 |
| E23523840 | K162261 | 000 |
| E23523850 | K162261 | 000 |
| E23523860 | K162261 | 000 |
| E23523880 | K162261 | 000 |
| E23524010 | K162261 | 000 |
| E23524030 | K162261 | 000 |
| E23523680 | K162261 | 000 |
| E23523670 | K162261 | 000 |
| E23523480 | K162261 | 000 |
| E23523490 | K162261 | 000 |
| E23523500 | K162261 | 000 |
| E23523510 | K162261 | 000 |
| E23523550 | K162261 | 000 |
| E23523560 | K162261 | 000 |
| E23523570 | K162261 | 000 |
| E23523580 | K162261 | 000 |
| E23523590 | K162261 | 000 |
| E23523610 | K162261 | 000 |
| E23523620 | K162261 | 000 |
| E23523630 | K162261 | 000 |
| E23523640 | K162261 | 000 |
| E23523650 | K162261 | 000 |
| E23523660 | K162261 | 000 |
| E23524050 | K162261 | 000 |