Cleared Traditional

Integrated Endo System (Meet Endo-II)

K242317 · Denjoy Dental Co., Ltd. · Dental
Feb 2025
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K242317 is an FDA 510(k) clearance for the Integrated Endo System (Meet Endo-II), a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Denjoy Dental Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on February 13, 2025, 192 days after receiving the submission on August 5, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K242317 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2024
Decision Date February 13, 2025
Days to Decision 192 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELC — Scaler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4850

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