The following data is part of a premarket notification filed by G-c Intl. Corp. with the FDA for Miracle Mix Caps Glass Ionomer Cement Incapsules.
| Device ID | K913175 |
| 510k Number | K913175 |
| Device Name: | MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES |
| Classification | Alloy, Amalgam |
| Applicant | G-C INTL. CORP. 7830 E.REDFIELD RD. STE.12 (GC TELLS OF FIRM CLOSING) Scottsdale, AZ 85260 |
| Contact | William R Jacobs |
| Correspondent | William R Jacobs G-C INTL. CORP. 7830 E.REDFIELD RD. STE.12 (GC TELLS OF FIRM CLOSING) Scottsdale, AZ 85260 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-17 |
| Decision Date | 1991-12-27 |