The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Universal Opaque.
| Device ID | K131504 |
| 510k Number | K131504 |
| Device Name: | UNIVERSAL OPAQUE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SHOFU DENTAL CORPORATION 1225 STONE DRIVE San Marcos, CA 92078 |
| Contact | David P Morais |
| Correspondent | David P Morais 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 | 2013-05-24 |
| Decision Date | 2013-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23521110 | K131504 | 000 |
| E23520940 | K131504 | 000 |
| E23520930 | K131504 | 000 |
| E23520920 | K131504 | 000 |
| E23520910 | K131504 | 000 |
| E23520900 | K131504 | 000 |
| E23520890 | K131504 | 000 |
| E23520880 | K131504 | 000 |
| E23520870 | K131504 | 000 |
| E23520860 | K131504 | 000 |
| E23520850 | K131504 | 000 |
| E23520840 | K131504 | 000 |
| E23520830 | K131504 | 000 |
| E23520820 | K131504 | 000 |
| E23520810 | K131504 | 000 |
| E23520950 | K131504 | 000 |
| E23520960 | K131504 | 000 |
| E23521100 | K131504 | 000 |
| E23521090 | K131504 | 000 |
| E23521080 | K131504 | 000 |
| E23521070 | K131504 | 000 |
| E23521060 | K131504 | 000 |
| E23521050 | K131504 | 000 |
| E23521040 | K131504 | 000 |
| E23521030 | K131504 | 000 |
| E23521020 | K131504 | 000 |
| E23521010 | K131504 | 000 |
| E23521000 | K131504 | 000 |
| E23520990 | K131504 | 000 |
| E23520980 | K131504 | 000 |
| E23520970 | K131504 | 000 |
| E23520800 | K131504 | 000 |