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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 K101140
Device Name DENTLIGHT ORAL EXAM LIGHT KIT
Applicant
DENTLIGHT INC.
1411 E. CAMPBELL RD
SUITE 500
RICHARDSON,  TX  75081
Applicant Contact RICHARD LIU
Correspondent
DENTLIGHT INC.
1411 E. CAMPBELL RD
SUITE 500
RICHARDSON,  TX  75081
Correspondent Contact RICHARD LIU
Regulation Number872.6350
Classification Product Code
NXV  
Subsequent Product Code
EAQ  
Date Received04/22/2010
Decision Date 07/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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