DEGUFILL (R) M

Material, Tooth Shade, Resin

DEGUSSA AG

The following data is part of a premarket notification filed by Degussa Ag with the FDA for Degufill (r) M.

Pre-market Notification Details

Device IDK901868
510k NumberK901868
Device Name:DEGUFILL (R) M
ClassificationMaterial, Tooth Shade, Resin
Applicant DEGUSSA AG POSTFACH 110533 D-6000 FRANKFURT 11 West Germany,  DE
ContactMackert
CorrespondentMackert
DEGUSSA AG POSTFACH 110533 D-6000 FRANKFURT 11 West Germany,  DE
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-24
Decision Date1990-08-14

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