DURAFILL MICROFILL RESTORATIVE MATERIAL

Material, Tooth Shade, Resin

KULZER, INC.

The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Durafill Microfill Restorative Material.

Pre-market Notification Details

Device IDK811669
510k NumberK811669
Device Name:DURAFILL MICROFILL RESTORATIVE MATERIAL
ClassificationMaterial, Tooth Shade, Resin
Applicant KULZER, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-06-15
Decision Date1981-07-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
J014660024990 K811669 000
J014660000170 K811669 000
J014660000160 K811669 000
J014660000150 K811669 000
J014660000140 K811669 000
J014660000130 K811669 000
J014660000120 K811669 000
J014660000110 K811669 000
J014660000100 K811669 000
J014660000090 K811669 000
J014660000180 K811669 000
J014660000190 K811669 000
J014660000200 K811669 000
J014660000300 K811669 000
J014660000290 K811669 000
J014660000280 K811669 000
J014660000270 K811669 000
J014660000260 K811669 000
J014660000250 K811669 000
J014660000230 K811669 000
J014660000220 K811669 000
J014660000210 K811669 000
J014660000080 K811669 000

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