Clearance Summary
GBT Machine Airflow Prophylaxis Master received FDA 510(k) clearance under submission number K253254, sponsored by E.M.S Electro Medical Systems S.A. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2026-01-28.
- Submission: K253254
- Applicant / Sponsor: E.M.S Electro Medical Systems S.A
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4850
- Decision date: 2026-01-28
Classification & Regulation
This clearance is catalogued under FDA product code ELC and 21 CFR 872.4850, within the Dental review panel as a Class II device.