Clearance Summary
MATCHMAKER/PROPAQUE PORCELAIN received FDA 510(k) clearance under submission number K960770, 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 1996-11-19.
- Submission: K960770
- Applicant / Sponsor: Davis Schottlander & Davis, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3920
- Decision date: 1996-11-19
Classification & Regulation
This clearance is catalogued under FDA product code ELL and 21 CFR 872.3920, within the Dental review panel as a Class II device.