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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K022974
Device Name MICROHYBRID 12
Applicant
Ab Ardent
54 Riverview Ave.
Tonawanda,  NY  14150 -5260
Applicant Contact CLYDE E INGERSOLL
Correspondent
Ab Ardent
54 Riverview Ave.
Tonawanda,  NY  14150 -5260
Correspondent Contact CLYDE E INGERSOLL
Regulation Number872.3690
Classification Product Code
EBF  
Date Received09/06/2002
Decision Date 11/22/2002
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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