GRANITEC Z2, ZINC PHOSPHATE CEMENT

Cement, Dental

CONFI-DENTAL PRODUCTS CO.

The following data is part of a premarket notification filed by Confi-dental Products Co. with the FDA for Granitec Z2, Zinc Phosphate Cement.

Pre-market Notification Details

Device IDK896649
510k NumberK896649
Device Name:GRANITEC Z2, ZINC PHOSPHATE CEMENT
ClassificationCement, Dental
Applicant CONFI-DENTAL PRODUCTS CO. 385 S. PIERCE AVE. COLORADO TECH CENTER Louisville,  CO  80027 -3017
ContactBrahma D Sharma,phd
CorrespondentBrahma D Sharma,phd
CONFI-DENTAL PRODUCTS CO. 385 S. PIERCE AVE. COLORADO TECH CENTER Louisville,  CO  80027 -3017
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-24
Decision Date1990-02-22

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