FDA 510(k) Application Details - K051931

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K051931
Device Name Material, Tooth Shade, Resin
Applicant TRI DENTAL INNOVATORS
13902 WEST ST., UNIT C
GARDEN GROVE, CA 92843 US
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Contact LINDA NGUYEN
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 07/13/2005
Decision Date 02/17/2006
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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