Cleared Traditional

ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM

K140685 · Sybron Endo · Dental
Jul 2014
Decision
106d
Days
Class 1
Risk

About This 510(k) Submission

K140685 is an FDA 510(k) clearance for the ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM, a Handpiece, Air-powered, Root Canal Irrigation (Class I — General Controls, product code NYL), submitted by Sybron Endo (Orange, US). The FDA issued a Cleared decision on July 2, 2014, 106 days after receiving the submission on March 18, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K140685 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2014
Decision Date July 02, 2014
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NYL — Handpiece, Air-powered, Root Canal Irrigation
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200
Definition To Clean The Root Canal Prior To Filling And Used For Root Canal Irrigation.