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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 K052463
Device Name PROMETAL HN86
Applicant
Prometal Technologies
67 Main St.
Silver Creek,  NY  14136
Applicant Contact DONNA MARIE HARTNETT
Correspondent
Prometal Technologies
67 Main St.
Silver Creek,  NY  14136
Correspondent Contact DONNA MARIE HARTNETT
Regulation Number872.3060
Classification Product Code
EJT  
Date Received09/08/2005
Decision Date 10/14/2005
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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