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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K071674
Device Name GC-ZIRCONIA
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 Number872.6660
Classification Product Code
EIH  
Date Received06/19/2007
Decision Date 08/09/2007
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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