Clearance Summary
EMA 3D received FDA 510(k) clearance under submission number K232735, sponsored by Ema Sleep Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2024-05-03.
- Submission: K232735
- Applicant / Sponsor: Ema Sleep Incorporated
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2024-05-03
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.