Cleared Traditional

The Trust

K222688 · Genoss Co., Ltd. · Dental
Aug 2024
Decision
703d
Days
Class 1
Risk

About This 510(k) Submission

K222688 is an FDA 510(k) clearance for the The Trust, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Genoss Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on August 9, 2024, 703 days after receiving the submission on September 6, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K222688 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2022
Decision Date August 09, 2024
Days to Decision 703 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

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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