Cleared Traditional

iCTmotor (WL-1) (K193341) - FDA 510(k) Clearance

Class I Dental device.

K193341 · Dentium Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
276d
Days
Class 1
Risk

K193341 is an FDA 510(k) clearance for the iCTmotor (WL-1). Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Dentium Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on September 4, 2020 after a review of 276 days - an extended review cycle.

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. Standard predicate reliance. 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 Dentium Co., Ltd. devices

Submission Details

510(k) Number K193341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2019
Decision Date September 04, 2020
Days to Decision 276 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
149d slower than avg
Panel avg: 127d · This submission: 276d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBW Controller, Foot, Handpiece And Cord
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

Mtechgroup
Dave Kim

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 - EBW Controller, Foot, Handpiece And Cord

All 20
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K193341.
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Surgic Pro, Surgic Pro+
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