Cleared Traditional

K243911 - HPR Cordless Hygiene Handpiece (FDA 510(k) Clearance)

Class I Dental device.

K243911 · Handpiece Headquarters · Dental device
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Dec 2024
Decision
1d
Days
Class 1
Risk

K243911 is an FDA 510(k) clearance for the HPR Cordless Hygiene Handpiece. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Handpiece Headquarters (Placentia, US). The FDA issued a Cleared decision on December 20, 2024 after a review of 1 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Handpiece Headquarters devices

Submission Details

510(k) Number K243911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2024
Decision Date December 20, 2024
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 127d · This submission: 1d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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

Regulatory Technology Services, LLC
Prithul Bom

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 88
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K243911.
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ChecQ (AC100)
K241065 · Dentis Co., Ltd. · Mar 2025
The Trust
K222688 · Genoss Co., Ltd. · Aug 2024