CUTTERSIL COMFORT HARDENER

Material, Impression

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Cuttersil Comfort Hardener.

Pre-market Notification Details

Device IDK965165
510k NumberK965165
Device Name:CUTTERSIL COMFORT HARDENER
ClassificationMaterial, Impression
Applicant HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
ContactCheryl V Zimmerman
CorrespondentCheryl V Zimmerman
HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-24
Decision Date1997-03-19

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