76 EMA LINING CEMENT

Cement, Dental

G-C INTL. CORP.

The following data is part of a premarket notification filed by G-c Intl. Corp. with the FDA for 76 Ema Lining Cement.

Pre-market Notification Details

Device IDK851468
510k NumberK851468
Device Name:76 EMA LINING CEMENT
ClassificationCement, Dental
Applicant G-C INTL. CORP. 7830 E.REDFIELD RD. STE.12 (GC TELLS OF FIRM CLOSING) Scottsdale,  AZ  85260
ContactDonald A Mckenzie
CorrespondentDonald A Mckenzie
G-C INTL. CORP. 7830 E.REDFIELD RD. STE.12 (GC TELLS OF FIRM CLOSING) Scottsdale,  AZ  85260
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-16
Decision Date1985-05-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
24548161329382 K851468 000
24548161329375 K851468 000
24548161329368 K851468 000

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