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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K013506
Device Name YELLOW SPECIAL
Applicant
Metalor Technologies USA
255 John L. Dietsch Blvd.
North Attleborough,  MA  02761
Applicant Contact BRUCE BARTON
Correspondent
Metalor Technologies USA
255 John L. Dietsch Blvd.
North Attleborough,  MA  02761
Correspondent Contact BRUCE BARTON
Regulation Number872.3060
Classification Product Code
EJT  
Date Received10/22/2001
Decision Date 01/03/2002
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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