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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K253254
Device Name GBT Machine Airflow Prophylaxis Master
Applicant
E.M.S Electro Medical Systems S.A
Ch. De La Vuarpillière 31
Nyon,  CH 1260
Applicant Contact Florian Bertrand
Correspondent
Heyer Regulatory Solutions
125 Cherry Ln.
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number872.4850
Classification Product Code
ELC  
Subsequent Product Code
KOJ  
Date Received09/29/2025
Decision Date 01/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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