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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 K993474
Device Name DELTAPAL, ALLOY NO. 5161
Applicant
Metalor Dental USA Corp.
255 John L. Dietsch Blvd.
North Attleborough,  MA  02761
Applicant Contact KENNETH A PUTNEY
Correspondent
Metalor Dental USA Corp.
255 John L. Dietsch Blvd.
North Attleborough,  MA  02761
Correspondent Contact KENNETH A PUTNEY
Regulation Number872.3060
Classification Product Code
EJS  
Date Received10/14/1999
Decision Date 12/02/1999
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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