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 ID: K092020
• 510k Number: K092020
• Device Name: AADVA ZR COLORING LIQUID
• Classification: Powder, Porcelain
• Applicant: GC AMERICA INC. 3737 WEST 127TH STREET Alsip, IL 60803
• Contact: Mark Heiss
• Correspondent: Mark Heiss; GC AMERICA INC. 3737 WEST 127TH STREET Alsip, IL 60803
• Product Code: EIH
• CFR Regulation Number: 872.6660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-07-06
• Decision Date: 2009-09-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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