The following data is part of a premarket notification filed by G-c Intl. Corp. with the FDA for Fuji Lining Cement Light Cure.
| Device ID | K901999 |
| 510k Number | K901999 |
| Device Name: | FUJI LINING CEMENT LIGHT CURE |
| Classification | Liner, Cavity, Calcium Hydroxide |
| 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 | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-02 |
| Decision Date | 1990-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24548161294307 | K901999 | 000 |
| 24548161293607 | K901999 | 000 |
| 24548161282830 | K901999 | 000 |