Cleared Traditional

Dental Electrical Motor iRoot Pro (K191276) - FDA 510(k) Clearance

Class I Dental device.

K191276 · Changzhou Bomedent Medical Technology Co.,Ltd · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
414d
Days
Class 1
Risk

K191276 is an FDA 510(k) clearance for the Dental Electrical Motor iRoot Pro. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Changzhou Bomedent Medical Technology Co.,Ltd (Changzhou, CN). The FDA issued a Cleared decision on June 30, 2020 after a review of 414 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 Changzhou Bomedent Medical Technology Co.,Ltd devices

Submission Details

510(k) Number K191276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2019
Decision Date June 30, 2020
Days to Decision 414 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
287d slower than avg
Panel avg: 127d · This submission: 414d
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

Beijing Believe-Med Technology Service Co., Ltd.
Ray Wang

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 K191276.
Endo Motor
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Osstell Beacon
K181888 · Osstell AB · Aug 2019
AeroPro Cordless Prophy System
K180682 · Premier Dental Company Products · Feb 2019
AnyCheck IMT-100
K180953 · Dms Co., Ltd. · Feb 2019