Clearance Summary
Morpheus received FDA 510(k) clearance under submission number K210636, sponsored by S4S UK , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2022-02-15.
- Submission: K210636
- Applicant / Sponsor: S4S UK , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2022-02-15
Classification & Regulation
This clearance is catalogued under FDA product code LRK and 21 CFR 872.5570, within the Dental review panel as a Class II device.