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510(k) K162436

EndoVac Pure by Kerr Corporation — Product Code NYL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2016
Date Received
August 31, 2016
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.

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  • K052271 — RINSENDO (May 26, 2006)