The following data is part of a premarket notification filed by G-c Intl. Corp. with the FDA for Fuji Ionomer Type I & Ii.
| Device ID | K811521 |
| 510k Number | K811521 |
| Device Name: | FUJI IONOMER TYPE I & II |
| Classification | Cement, Dental |
| Applicant | G-C INTL. 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 | 1981-05-29 |
| Decision Date | 1981-06-26 |