PROTEMP 3 GARANT

Crown And Bridge, Temporary, Resin

3M ESPE AG DENTAL PRODUCTS

The following data is part of a premarket notification filed by 3m Espe Ag Dental Products with the FDA for Protemp 3 Garant.

Pre-market Notification Details

Device IDK033022
510k NumberK033022
Device Name:PROTEMP 3 GARANT
ClassificationCrown And Bridge, Temporary, Resin
Applicant 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria,  DE D-82229
ContactAndreas Petermann
CorrespondentAndreas Petermann
3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria,  DE D-82229
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-25
Decision Date2003-11-21
Summary:summary

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