SCOTCHBOND DENTAL ADHESIVE

Agent, Tooth Bonding, Resin

3M COMPANY

The following data is part of a premarket notification filed by 3m Company with the FDA for Scotchbond Dental Adhesive.

Pre-market Notification Details

Device IDK813180
510k NumberK813180
Device Name:SCOTCHBOND DENTAL ADHESIVE
ClassificationAgent, Tooth Bonding, Resin
Applicant 3M COMPANY 8124 PACIFIC AVE. White City,  OR  97503
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-12
Decision Date1982-01-12

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