FDA 510(k) Application Details - K052593

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K052593
Device Name Activator, Ultraviolet, For Polymerization
Applicant DENTLIGHT INC.
4404 BRECKINRIDGE BLVD.
DUITE 400
RICHARDSON, TX 75082 US
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Contact RICHARD LIU
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 09/21/2005
Decision Date 09/28/2005
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 Y
Expedited Review



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