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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name adhesive, bracket and tooth conditioner, resin
510(k) Number K143667
Device Name GC KommonBase
Applicant
GC Orthodontics America Inc.
11535 S.Central Avenue
Alsip,  IL  60803
Applicant Contact Tom Macari
Correspondent
GC America Inc.
3737 W. 127th Street
Alsip,  IL  60803
Correspondent Contact Dr. Mark Heiss
Regulation Number872.3750
Classification Product Code
DYH  
Date Received12/23/2014
Decision Date 05/07/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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