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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 K914627
Device Name PLATINUM FOIL PLATINUM MILING WAFER
Applicant
Metalor Dental USA Corp.
457 Laurel Rd.
Box 369
Rockville Centre,  NY  11571 -0369
Applicant Contact BRIAN F SCHILLER
Correspondent
Metalor Dental USA Corp.
457 Laurel Rd.
Box 369
Rockville Centre,  NY  11571 -0369
Correspondent Contact BRIAN F SCHILLER
Regulation Number872.3060
Classification Product Code
EJS  
Date Received10/16/1991
Decision Date 11/13/1991
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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