Clearance Summary
TopCEM Ceramic Primer Ceramic Coupling Agent received FDA 510(k) clearance under submission number K242749, sponsored by Rizhao Huge Biomaterials Company, 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 2024-11-08.
- Submission: K242749
- Applicant / Sponsor: Rizhao Huge Biomaterials Company, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3200
- Decision date: 2024-11-08
Classification & Regulation
This clearance is catalogued under FDA product code KLE and 21 CFR 872.3200, within the Dental review panel as a Class II device.