The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Resiglass Paste.
| Device ID | K112307 |
| 510k Number | K112307 |
| Device Name: | RESIGLASS PASTE |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-11 |
| Decision Date | 2012-03-28 |