Clearance Summary
INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA received FDA 510(k) clearance under submission number K142043, sponsored by Jensen Industries, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2014-12-18.
- Submission: K142043
- Applicant / Sponsor: Jensen Industries, Inc.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2014-12-18
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.