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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Amalgam
510(k) Number K031658
Device Name BENCO SPHERICAL
Applicant
Southern Dental Industries, Inc.
729 N. Rte. 83, Suite 315
Bensenville,  IL  60106
Applicant Contact SAMANTHA J CHEETHAM
Correspondent
Southern Dental Industries, Inc.
729 N. Rte. 83, Suite 315
Bensenville,  IL  60106
Correspondent Contact SAMANTHA J CHEETHAM
Regulation Number872.3070
Classification Product Code
EJJ  
Date Received05/28/2003
Decision Date 07/29/2003
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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