Cleared Traditional

ChecQ (AC100)

K241065 · Dentis Co., Ltd. · Dental
Mar 2025
Decision
337d
Days
Class 1
Risk

About This 510(k) Submission

K241065 is an FDA 510(k) clearance for the ChecQ (AC100), a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Dentis Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on March 21, 2025, 337 days after receiving the submission on April 18, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K241065 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2024
Decision Date March 21, 2025
Days to Decision 337 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

Similar Devices — EKX Handpiece, Direct Drive, Ac-powered

All 88
Alpha Endo Handpiece (Alpha Endo)
K252223 · SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. · Oct 2025
InnerView System
K251597 · Perimetrics, Inc. · Sep 2025
EnDrive (EnDriveUS)
K243692 · Advanced Technology Research (A.T.R.) S.R.L. · Aug 2025
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
K242514 · Shenzhen Rogin Medical Co., Ltd. · Apr 2025
HPR Cordless Hygiene Handpiece
K243911 · Handpiece Headquarters · Dec 2024
The Trust
K222688 · Genoss Co., Ltd. · Aug 2024