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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K021038
Device Name GC ELITE CEMENT 100
Applicant
GC America, Inc.
3737 W 127th St.
Alsip,  IL  60803
Applicant Contact TERRY L JORITZ
Correspondent
GC America, Inc.
3737 W 127th St.
Alsip,  IL  60803
Correspondent Contact TERRY L JORITZ
Regulation Number872.3275
Classification Product Code
EMA  
Date Received04/01/2002
Decision Date 05/03/2002
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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