DENTACOLOR(R) CRE-ACTIVE

Material, Tooth Shade, Resin

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Dentacolor(r) Cre-active.

Pre-market Notification Details

Device IDK914456
510k NumberK914456
Device Name:DENTACOLOR(R) CRE-ACTIVE
ClassificationMaterial, Tooth Shade, 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 CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-07
Decision Date1992-03-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
J014660334680 K914456 000
J014660334470 K914456 000
J014660334480 K914456 000
J014660334490 K914456 000
J014660334500 K914456 000
J014660334610 K914456 000
J014660334620 K914456 000
J014660334630 K914456 000
J014660334640 K914456 000
J014660334650 K914456 000
J014660334660 K914456 000
J014660334450 K914456 000

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