Clearance Summary
Elastic Impression Material received FDA 510(k) clearance under submission number K241924, sponsored by Beijing Okvd Biological Technology , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2024-12-27.
- Submission: K241924
- Applicant / Sponsor: Beijing Okvd Biological Technology , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 2024-12-27
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.