DUCERAGOLD, DUCERATIN

Teeth, Porcelain

DEGUSSA AG

The following data is part of a premarket notification filed by Degussa Ag with the FDA for Duceragold, Duceratin.

Pre-market Notification Details

Device IDK931808
510k NumberK931808
Device Name:DUCERAGOLD, DUCERATIN
ClassificationTeeth, Porcelain
Applicant DEGUSSA AG 3950 SOUTH CLINTON AVE. South Plainfield,  NJ  07080
ContactHolger Meinicke
CorrespondentHolger Meinicke
DEGUSSA AG 3950 SOUTH CLINTON AVE. South Plainfield,  NJ  07080
Product CodeELL  
CFR Regulation Number872.3920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-12
Decision Date1993-11-03

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