FDA 510(k) Application Details - K101140

Device Classification Name

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510(K) Number K101140
Device Name DENTLIGHT ORAL EXAM LIGHT KIT
Applicant DENTLIGHT INC.
1411 E. CAMPBELL RD
SUITE 500
RICHARDSON, TX 75081 US
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Contact RICHARD LIU
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Regulation Number

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Classification Product Code NXV
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Date Received 04/22/2010
Decision Date 07/15/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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