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FDA 510(k) Application Details - K140685
Device Classification Name
Handpiece, Air-Powered, Root Canal Irrigation
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510(K) Number
K140685
Device Name
Handpiece, Air-Powered, Root Canal Irrigation
Applicant
SYBRONENDO
1717 W.COLLINS AVENUE
ORANGE, CA 92867 US
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Contact
COURTNEY CLARK
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Regulation Number
872.4200
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Classification Product Code
NYL
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More FDA Info for this Product Code
Date Received
03/18/2014
Decision Date
07/02/2014
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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