ALGINATE IMPRESSION MATERIAL

Material, Impression

DENTSPLY INTL.

The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Alginate Impression Material.

Pre-market Notification Details

Device IDK802362
510k NumberK802362
Device Name:ALGINATE IMPRESSION MATERIAL
ClassificationMaterial, Impression
Applicant DENTSPLY INTL. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-09-26
Decision Date1980-10-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D6620708490672 K802362 000
D6620708490422 K802362 000

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