RESTODENT POSTERIOR

Material, Tooth Shade, Resin

LEE PHARMACEUTICALS

The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Restodent Posterior.

Pre-market Notification Details

Device IDK863157
510k NumberK863157
Device Name:RESTODENT POSTERIOR
ClassificationMaterial, Tooth Shade, Resin
Applicant LEE PHARMACEUTICALS 1444 SANTA ANITA P.O. BOX 3836 South El Monte,  CA  91733
ContactTeigler, Ph.d.
CorrespondentTeigler, Ph.d.
LEE PHARMACEUTICALS 1444 SANTA ANITA P.O. BOX 3836 South El Monte,  CA  91733
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-15
Decision Date1986-09-25

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