Cleared Traditional

Endo Motor (K192649) - FDA 510(k) Clearance

Class I Dental device.

K192649 · Foshan Cicada Dental Instrument Co, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
535d
Days
Class 1
Risk

K192649 is an FDA 510(k) clearance for the Endo Motor. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Foshan Cicada Dental Instrument Co, Ltd. (Nanhai District, Foshan, CN). The FDA issued a Cleared decision on March 12, 2021 after a review of 535 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Foshan Cicada Dental Instrument Co, Ltd. devices

Submission Details

510(k) Number K192649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2019
Decision Date March 12, 2021
Days to Decision 535 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
408d slower than avg
Panel avg: 127d · This submission: 535d
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

Guangzhou Keda Biological Tech Co., Ltd.
Jet Li

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 28
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K192649.
TRAUS ENDO
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E-connect S Endo Motor with built-in Apex Locator
K201993 · Changzhou Sifary Medical Technology Co., Ltd. · Jan 2021
Dental Electrical Motor iRoot Pro
K191276 · Changzhou Bomedent Medical Technology Co.,Ltd · Jun 2020