Cleared Traditional

HPR Cordless Hygiene Handpiece

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

About This 510(k) Submission

K243911 is an FDA 510(k) clearance for the HPR Cordless Hygiene Handpiece, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Handpiece Headquarters (Placentia, US). The FDA issued a Cleared decision on December 20, 2024, 1 days after receiving the submission on December 19, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K243911 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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