Clearance Summary
ROOT CANAL XR received FDA 510(k) clearance under submission number K083062, sponsored by S & C Polymer GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-03-12.
- Submission: K083062
- Applicant / Sponsor: S & C Polymer GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3820
- Decision date: 2009-03-12
Classification & Regulation
This clearance is catalogued under FDA product code KIF and 21 CFR 872.3820, within the Dental review panel as a Class II device.