FDA 510(k) Application Details - K071288

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K071288
Device Name Material, Tooth Shade, Resin
Applicant SYBRON DENTAL SPECIALTIES, INC.
1717 W. COLLINS AVE.
ORANGE, CA 92867 US
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Contact COLLEEN BOSWELL
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 05/08/2007
Decision Date 07/19/2007
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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