PALAVIT 55 AND DENTACOLOR CONNECTOR

Crown And Bridge, Temporary, Resin

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Palavit 55 And Dentacolor Connector.

Pre-market Notification Details

Device IDK932034
510k NumberK932034
Device Name:PALAVIT 55 AND DENTACOLOR CONNECTOR
ClassificationCrown And Bridge, Temporary, Resin
Applicant HERAEUS KULZER, INC. 10005 MUIRLANDS BLVD. Irvine,  CA  92718 -2595
ContactSharon Parker
CorrespondentSharon Parker
HERAEUS KULZER, INC. 10005 MUIRLANDS BLVD. Irvine,  CA  92718 -2595
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-27
Decision Date1993-08-06

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