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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 K895058
Device Name HIGH FUSING WHITE CERAMIC SOLDER
Applicant
Leach and Dillon Co., Inc.
171 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact CHERI KRATZ
Correspondent
Leach and Dillon Co., Inc.
171 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact CHERI KRATZ
Regulation Number872.3060
Classification Product Code
EJT  
Date Received08/08/1989
Decision Date 10/05/1990
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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