The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Glas Ionomer Cement.
| Device ID | K841195 |
| 510k Number | K841195 |
| Device Name: | GLAS IONOMER CEMENT |
| Classification | Cement, Dental |
| Applicant | SHOFU DENTAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-21 |
| Decision Date | 1984-05-14 |