Cleared Traditional

GBT Machine Airflow Prophylaxis Master

K253254 · E.M.S Electro Medical Systems S.A · Dental
Jan 2026
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K253254 is an FDA 510(k) clearance for the GBT Machine Airflow Prophylaxis Master, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on January 28, 2026, 121 days after receiving the submission on September 29, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K253254 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2025
Decision Date January 28, 2026
Days to Decision 121 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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