SUMMAR NON-PRECIOUS, CERAMIC ALLOY

Alloy, Metal, Base

SHOFU DENTAL CORP.

The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Summar Non-precious, Ceramic Alloy.

Pre-market Notification Details

Device IDK811013
510k NumberK811013
Device Name:SUMMAR NON-PRECIOUS, CERAMIC ALLOY
ClassificationAlloy, Metal, Base
Applicant SHOFU DENTAL CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEJH  
CFR Regulation Number872.3710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-04-15
Decision Date1981-06-26

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