Clearance Summary
AMADEO, M-UK1015 (incl. attachments and accessories) received FDA 510(k) clearance under submission number K213221, sponsored by W&H Dentalwerk Buermoss GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2022-05-26.
- Submission: K213221
- Applicant / Sponsor: W&H Dentalwerk Buermoss GmbH
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4250
- Decision date: 2022-05-26
Classification & Regulation
This clearance is catalogued under FDA product code ERL and 21 CFR 874.4250, within the Ear, Nose, Throat review panel as a Class II device.