510(k) K103244

QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION by Dentsply Intl., Inc. — Product Code KJJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2011
Date Received
November 2, 2010
Clearance Type
Traditional
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