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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K913854
Device Name ORTHO LIGHT CURE
Applicant
Ortho Source
12021 Riverside Dr.
Suite 201
North Hollywood,  CA  91607
Applicant Contact ANDREA G MUSTACHIO
Correspondent
Ortho Source
12021 Riverside Dr.
Suite 201
North Hollywood,  CA  91607
Correspondent Contact ANDREA G MUSTACHIO
Regulation Number872.3750
Classification Product Code
DYH  
Date Received08/27/1991
Decision Date 01/14/1992
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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