Clearance Summary
Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip received FDA 510(k) clearance under submission number K192033, sponsored by Bennett Jacoby, Dds, Ms, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-06-09.
- Submission: K192033
- Applicant / Sponsor: Bennett Jacoby, Dds, Ms, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4120
- Decision date: 2020-06-09
Classification & Regulation
This clearance is catalogued under FDA product code DZI and 21 CFR 872.4120, within the Dental review panel as a Class II device.