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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 K873373
Device Name SINTERLOY
Applicant
Denpac Corp.
85 Myer St.
Hackensack,  NJ  07601
Applicant Contact BELL, DDS
Correspondent
Denpac Corp.
85 Myer St.
Hackensack,  NJ  07601
Correspondent Contact BELL, DDS
Regulation Number872.3060
Classification Product Code
EJS  
Date Received08/24/1987
Decision Date 10/27/1987
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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