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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K062065
Device Name RIVA LUTING PLUS
Applicant
Southern Dental Industries, Inc.
729 N. Route 83, Suite 315
Bensenville,  IL  60106
Applicant Contact RAY CAHILL
Correspondent
Southern Dental Industries, Inc.
729 N. Route 83, Suite 315
Bensenville,  IL  60106
Correspondent Contact RAY CAHILL
Regulation Number872.3275
Classification Product Code
EMA  
Date Received07/20/2006
Decision Date 11/15/2006
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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