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510(k) K100606

VATEA ENDONTIC IRRIGATION SYSTEM by Redent Nova, Ltd. — Product Code NYL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 28, 2010
Date Received: March 3, 2010
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Handpiece, Air-Powered, Root Canal Irrigation
Device Class: Class I
Regulation Number: 872.4200
Review Panel: DE
Submission Type

To clean the root canal prior to filling and used for root canal irrigation.