Cleared Traditional

BioSonic US200 Ultrasonic Scaler (60034537)

K240801 · Dent4you AG · Dental
Jul 2024
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K240801 is an FDA 510(k) clearance for the BioSonic US200 Ultrasonic Scaler (60034537), a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Dent4you AG (Heerbrugg, CH). The FDA issued a Cleared decision on July 1, 2024, 98 days after receiving the submission on March 25, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K240801 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2024
Decision Date July 01, 2024
Days to Decision 98 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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