Cleared Traditional

PS System

K211721 · Inter-Med, Inc. · Dental
Dec 2021
Decision
181d
Days
Class 1
Risk

About This 510(k) Submission

K211721 is an FDA 510(k) clearance for the PS System, a Handpiece, Air-powered, Root Canal Irrigation (Class I — General Controls, product code NYL), submitted by Inter-Med, Inc. (Racine, US). The FDA issued a Cleared decision on December 2, 2021, 181 days after receiving the submission on June 4, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K211721 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2021
Decision Date December 02, 2021
Days to Decision 181 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.