AADVA ZR COLORING LIQUID

Powder, Porcelain

GC AMERICA INC.

The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Aadva Zr Coloring Liquid.

Pre-market Notification Details

Device IDK092020
510k NumberK092020
Device Name:AADVA ZR COLORING LIQUID
ClassificationPowder, Porcelain
Applicant GC AMERICA INC. 3737 WEST 127TH STREET Alsip,  IL  60803
ContactMark Heiss
CorrespondentMark Heiss
GC AMERICA INC. 3737 WEST 127TH STREET Alsip,  IL  60803
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-06
Decision Date2009-09-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EDMC4000LQ70500 K092020 000
EDMC4000LQ70620 K092020 000
EDMC4000LQ70630 K092020 000
EDMC4000LQ70640 K092020 000
EDMC4000LQ70650 K092020 000
EDMC4000LQ70660 K092020 000
EDMC4000LQ71000 K092020 000
EDMC4000LQ71010 K092020 000
EDMC4000LQ71020 K092020 000
EDMC4000LQ70610 K092020 000
EDMC4000LQ70600 K092020 000
EDMC4000LQ70590 K092020 000
EDMC4000LQ70510 K092020 000
EDMC4000LQ70520 K092020 000
EDMC4000LQ70530 K092020 000
EDMC4000LQ70540 K092020 000
EDMC4000LQ70550 K092020 000
EDMC4000LQ70560 K092020 000
EDMC4000LQ70570 K092020 000
EDMC4000LQ70580 K092020 000
EDMC4000LQ71030 K092020 000
EDMC4000LQ71040 K092020 000
EDMC4000LQ71160 K092020 000
EDMC4000LQ80200 K092020 000
EDMC4000LQ80210 K092020 000
EDMC4000LQ80270 K092020 000
EDMC4000LQ80310 K092020 000
EDMC4000LQ80330 K092020 000
EDMC4000LQ80360 K092020 000
EDMC4000LQ80370 K092020 000
EDMC4000LQ71150 K092020 000
EDMC4000LQ71140 K092020 000
EDMC4000LQ71130 K092020 000
EDMC4000LQ71050 K092020 000
EDMC4000LQ71060 K092020 000
EDMC4000LQ71070 K092020 000
EDMC4000LQ71080 K092020 000
EDMC4000LQ71090 K092020 000
EDMC4000LQ71100 K092020 000
EDMC4000LQ71110 K092020 000
EDMC4000LQ71120 K092020 000
EDMC4000LQ80300 K092020 000

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