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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Other Noble Metal
510(k) Number K862856
Device Name PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR
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 Number872.3060
Classification Product Code
EJS  
Date Received07/29/1986
Decision Date 08/26/1986
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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