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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K994077
Device Name AROMA FINE (NORMAL AND FAST SET)
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 Number872.3660
Classification Product Code
ELW  
Date Received12/02/1999
Decision Date 01/27/2000
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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