Cleared Special

TRAUS ENDO (K212043) - FDA 510(k) Clearance

Class I Dental device.

K212043 · Saeshin Precision Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
359d
Days
Class 1
Risk

K212043 is an FDA 510(k) clearance for the TRAUS ENDO. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on June 24, 2022 after a review of 359 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Saeshin Precision Co., Ltd. devices

Submission Details

510(k) Number K212043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2021
Decision Date June 24, 2022
Days to Decision 359 days
Submission Type Special
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
232d slower than avg
Panel avg: 127d · This submission: 359d
Pathway characteristics
Modification to existing cleared device.

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

LK Consulting Group USA, Inc.
Priscilla Chung

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 K212043.
Endo Motor
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Endo Motor
K203320 · Guilin Woodpecker Medical Instrument Co., Ltd. · May 2021
Endo Motor
K192649 · Foshan Cicada Dental Instrument Co, Ltd. · Mar 2021