BONDALCAP (SILICO-PHOSPHATE)

Cement, Dental

VIVADENT (USA), INC.

The following data is part of a premarket notification filed by Vivadent (usa), Inc. with the FDA for Bondalcap (silico-phosphate).

Pre-market Notification Details

Device IDK801228
510k NumberK801228
Device Name:BONDALCAP (SILICO-PHOSPHATE)
ClassificationCement, Dental
Applicant VIVADENT (USA), INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-05-23
Decision Date1980-06-04

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