ARTGLASS & KEVLOC

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 Artglass & Kevloc.

Pre-market Notification Details

Device IDK954115
510k NumberK954115
Device Name:ARTGLASS & KEVLOC
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 Received1995-07-31
Decision Date1995-09-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
J014647142110 K954115 000

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