Cleared Traditional

K180953 - AnyCheck IMT-100 (FDA 510(k) Clearance)

Class I Dental device.

K180953 · Dms Co., Ltd. · Dental device
Feb 2019
Decision
315d
Days
Class 1
Risk

K180953 is an FDA 510(k) clearance for the AnyCheck IMT-100. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Dms Co., Ltd. (Wonju-Si, KR). The FDA issued a Cleared decision on February 20, 2019 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K180953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2018
Decision Date February 20, 2019
Days to Decision 315 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 158d · This submission: 315d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKX Handpiece, Direct Drive, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKX Handpiece, Direct Drive, Ac-powered

Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K180953.
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
ChecQ (AC100)
K241065 · Dentis Co., Ltd. · Mar 2025
X-Smart Pro
K233865 · Dentsply Sirona, Inc. · Jul 2024