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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 K050870
Device Name RIVA LIGHT CURE
Applicant
Southern Dental Industries, Inc.
5 Brunsdon St. 3125
Bayswater Vi 3125,  AU
Applicant Contact RAY CAHILL
Correspondent
Southern Dental Industries, Inc.
5 Brunsdon St. 3125
Bayswater Vi 3125,  AU
Correspondent Contact RAY CAHILL
Regulation Number872.3275
Classification Product Code
EMA  
Subsequent Product Codes
EBC   EBF  
Date Received04/06/2005
Decision Date 06/03/2005
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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