Endo Vac Apical Negative Pressure Irigation System

FDA 510(k) K140685 · Sybron Endo

Substantially Equivalent

510(k) numberK140685

Submission

Device name
Endo Vac Apical Negative Pressure Irigation System
Applicant
Sybron Endo
Orange, CA, US
Received
March 18, 2014
Decision date
July 2, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NYL – Handpiece, Air-Powered, Root Canal Irrigation
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

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

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K211721PS SystemNYL · Traditional Inter-Med, Inc.12/02/2021SE
K162436EndoVac PureNYL · Traditional Kerr Corporation12/21/2016SE
K100606Vatea Endontic Irrigation SystemNYL · Traditional Redent Nova, Ltd.05/28/2010SE
K052271RinsendoNYL · Traditional Air Techniques, Inc.05/26/2006SE

Questions and answers

When was Endo Vac Apical Negative Pressure Irigation System cleared by the FDA?

Endo Vac Apical Negative Pressure Irigation System (K140685) received a 510(k) decision of Substantially Equivalent on July 2, 2014, 106 days after the submission was received.

What is the product code of K140685?

The FDA product code is NYL – Handpiece, Air-Powered, Root Canal Irrigation, a Class I (low risk) device regulated under 21 CFR 872.4200.