Clearance Summary
ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM received FDA 510(k) clearance under submission number K140685, sponsored by Sybron Endo. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2014-07-02.
- Submission: K140685
- Applicant / Sponsor: Sybron Endo
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2014-07-02
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.