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510(k) K053167

BIOPURE MTAD ROOT CANAL CLEANSER by Dentsply Intl., Inc. — Product Code KJJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2005
Date Received
November 14, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleanser, Root Canal
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

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