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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liner, Cavity, Calcium Hydroxide
510(k) Number K884949
Device Name VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER
Applicant
Ortho Source
12021 Riverside Dr.
Suite 201
North Hollywood,  CA  91607
Applicant Contact TAYLOR, DDS
Correspondent
Ortho Source
12021 Riverside Dr.
Suite 201
North Hollywood,  CA  91607
Correspondent Contact TAYLOR, DDS
Regulation Number872.3250
Classification Product Code
EJK  
Date Received11/25/1988
Decision Date 02/23/1989
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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