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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diagnostic Light, Soft Tissue Detector
510(k) Number K123169
FOIA Releasable 510(k) K123169
Device Name ORALID
Applicant
Forward Science, LLC
2511 Wind Fall Ln.
Sugar Land,  TX  77479
Applicant Contact BRIAN PIKKULA
Correspondent
Forward Science, LLC
2511 Wind Fall Ln.
Sugar Land,  TX  77479
Correspondent Contact BRIAN PIKKULA
Regulation Number872.6350
Classification Product Code
NXV  
Date Received10/09/2012
Decision Date 03/13/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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