KETAC-FIL APLICAP PLUS

Cement, Dental

ESPE GMBH & CO. KG.

The following data is part of a premarket notification filed by Espe Gmbh & Co. Kg. with the FDA for Ketac-fil Aplicap Plus.

Pre-market Notification Details

Device IDK973262
510k NumberK973262
Device Name:KETAC-FIL APLICAP PLUS
ClassificationCement, Dental
Applicant ESPE GMBH & CO. KG. AM GRIESBERG 2 Seefeld,  DE D-82229
ContactBarbara Wagner-schuh
CorrespondentBarbara Wagner-schuh
ESPE GMBH & CO. KG. AM GRIESBERG 2 Seefeld,  DE D-82229
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-29
Decision Date1997-11-17
Summary:summary

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