Cleared Traditional

Young INFINITY Cordless Handpiece System

K171377 · Young Dental Manufacturing Co. 1, LLC · Dental
Aug 2018
Decision
467d
Days
Class 1
Risk

About This 510(k) Submission

K171377 is an FDA 510(k) clearance for the Young INFINITY Cordless Handpiece System, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Young Dental Manufacturing Co. 1, LLC (Earth City, US). The FDA issued a Cleared decision on August 20, 2018, 467 days after receiving the submission on May 10, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K171377 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2017
Decision Date August 20, 2018
Days to Decision 467 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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