Clearance Summary
MATCH PRESS PRESSABLE CERAMIC received FDA 510(k) clearance under submission number K024250, sponsored by Davis Schottlander & Davis, 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 2003-08-25.
- Submission: K024250
- Applicant / Sponsor: Davis Schottlander & Davis, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2003-08-25
Classification & Regulation
This clearance is catalogued under FDA product code EIH and 21 CFR 872.6660, within the Dental review panel as a Class II device.