Clearance Summary
VATEA ENDONTIC IRRIGATION SYSTEM received FDA 510(k) clearance under submission number K100606, sponsored by Redent Nova, 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 2010-05-28.
- Submission: K100606
- Applicant / Sponsor: Redent Nova, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2010-05-28
Classification & Regulation
This clearance is catalogued under FDA product code NYL and 21 CFR 872.4200, within the Dental review panel as a Class I device.