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510(k) K140685

ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM by Sybron Endo — Product Code NYL

K140685 is an FDA 510(k) premarket notification submitted by Sybron Endo for the device "ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 2, 2014. The device falls under product code NYL (Handpiece, Air-Powered, Root Canal Irrigation), a Class I device regulated under 21 CFR 872.4200.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 2, 2014
Date Received: March 18, 2014
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.