Clearance Summary
AMBARINO High-Class received FDA 510(k) clearance under submission number K222723, sponsored by Creamed GmbH & Co. Produktions- Und Handels KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2022-09-09.
- Submission: K222723
- Applicant / Sponsor: Creamed GmbH & Co. Produktions- Und Handels KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 2022-09-09
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.