FDA 510(k) Application Details - K063703

Device Classification Name Cleanser, Root Canal

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510(K) Number K063703
Device Name Cleanser, Root Canal
Applicant ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN, UT 84095 US
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Contact COREY JASEPH
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Regulation Number 000.0000

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Classification Product Code KJJ
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Date Received 12/13/2006
Decision Date 12/21/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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