Clearance Summary
EmbedMed received FDA 510(k) clearance under submission number K220366, sponsored by 3D Lifeprints 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 2022-09-30.
- Submission: K220366
- Applicant / Sponsor: 3D Lifeprints UK , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4120
- Decision date: 2022-09-30
Classification & Regulation
This clearance is catalogued under FDA product code DZJ and 21 CFR 872.4120, within the Dental review panel as a Class II device.