The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Veracia Sa.
| Device ID | K113426 |
| 510k Number | K113426 |
| Device Name: | VERACIA SA |
| Classification | Denture, Plastic, Teeth |
| 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 | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-18 |
| Decision Date | 2012-02-08 |