Cleared Traditional

K180953 - AnyCheck IMT-100

K180953 is the FDA 510(k) clearance for AnyCheck IMT-100 by Dms Co., Ltd.. It is a Class 1 Dental device (product code EKX) cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K180953 · Dms Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Dms Co., Ltd. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
188d slower than avg
Panel avg: 127d · 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 Consultant

Allura Medical Solution, Inc.
Hwi Joon Park

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 43
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K180953.
Dental Electrical Motor iRoot Pro
K191276 · Changzhou Bomedent Medical Technology Co.,Ltd · Jun 2020
Osstell Beacon
K181888 · Osstell AB · Aug 2019
AeroPro Cordless Prophy System
K180682 · Premier Dental Company Products · Feb 2019
LS OIL
K173920 · J. Morita USA, Inc. · Oct 2018
Young INFINITY Cordless Handpiece System
K171377 · Young Dental Manufacturing Co. 1, LLC · Aug 2018
IS3
K180527 · Hiossen, Inc. · May 2018