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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K864826
Device Name A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)
Applicant
Austenal Dental, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Applicant Contact MARK WOJTULEWICZ
Correspondent
Austenal Dental, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Correspondent Contact MARK WOJTULEWICZ
Regulation Number872.3710
Classification Product Code
EJH  
Date Received12/09/1986
Decision Date 02/10/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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