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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 K991974
Device Name FUTURA GLASS IONOMER SILVER REINFORCED
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 Number872.3275
Classification Product Code
EMA  
Date Received06/11/1999
Decision Date 09/17/1999
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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