VISIO-OPAQUER

Material, Tooth Shade, Resin

ESPE GMBH (US)

The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Visio-opaquer.

Pre-market Notification Details

Device IDK822453
510k NumberK822453
Device Name:VISIO-OPAQUER
ClassificationMaterial, Tooth Shade, Resin
Applicant ESPE GMBH (US) 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-16
Decision Date1982-09-14

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