The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Glasionomer Fx Ultra.
| Device ID | K222253 |
| 510k Number | K222253 |
| Device Name: | GlasIonomer FX ULTRA |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-27 |
| Decision Date | 2022-09-22 |