Clearance Summary
DD medical polymers (PMMA) received FDA 510(k) clearance under submission number K230410, sponsored by Dental Direkt GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-06-23.
- Submission: K230410
- Applicant / Sponsor: Dental Direkt GmbH
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 2023-06-23
Classification & Regulation
This clearance is catalogued under FDA product code EBI and 21 CFR 872.3760, within the Dental review panel as a Class II device.