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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coating, Filling Material, Resin
510(k) Number K052462
Device Name G-COAT
Applicant
GC America, Inc.
3737 W. 127th St.
Alsip,  IL  60803
Applicant Contact TERRY L JORITZ-LYONS
Correspondent
GC America, Inc.
3737 W. 127th St.
Alsip,  IL  60803
Correspondent Contact TERRY L JORITZ-LYONS
Regulation Number872.3310
Classification Product Code
EBD  
Date Received09/08/2005
Decision Date 10/20/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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