BONDING AGENT, PRESTIGE

Agent, Tooth Bonding, Resin

LEE PHARMACEUTICALS

The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Bonding Agent, Prestige.

Pre-market Notification Details

Device IDK760324
510k NumberK760324
Device Name:BONDING AGENT, PRESTIGE
ClassificationAgent, Tooth Bonding, Resin
Applicant LEE PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-07-26
Decision Date1976-08-03

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