RIVA LIGHT CURE

Cement, Dental

SOUTHERN DENTAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Southern Dental Industries, Inc. with the FDA for Riva Light Cure.

Pre-market Notification Details

Device IDK050870
510k NumberK050870
Device Name:RIVA LIGHT CURE
ClassificationCement, Dental
Applicant SOUTHERN DENTAL INDUSTRIES, INC. 5 BRUNSDON ST 3125 Bayswater Vi 3125,  AU
ContactRay Cahill
CorrespondentRay Cahill
SOUTHERN DENTAL INDUSTRIES, INC. 5 BRUNSDON ST 3125 Bayswater Vi 3125,  AU
Product CodeEMA  
Subsequent Product CodeEBC
Subsequent Product CodeEBF
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-06
Decision Date2005-06-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
DO3687300061 K050870 000
DO3687001081 K050870 000
DO3687001071 K050870 000
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DO3687000071 K050870 000
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DO3687300031 K050870 000
DO3687300021 K050870 000
DO3687300011 K050870 000
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DO3687005041 K050870 000
DO3687005031 K050870 000
DO3687005021 K050870 000
DO3687005011 K050870 000
DO3687001161 K050870 000
DO3687000011 K050870 000

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