FDA 510(k) Application Details - K070191

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K070191
Device Name Material, Tooth Shade, Resin
Applicant DENTAL TECHNOLOGIES, INC.
6901 NORTH HAMLIN AVE.
LINCOLNWOOD, IL 60712 US
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Contact JANINE RAUHUT
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 01/22/2007
Decision Date 03/07/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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