Clearance Summary
ROOT ZX II received FDA 510(k) clearance under submission number K071190, sponsored by J. Morita USA, 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 2007-08-17.
- Submission: K071190
- Applicant / Sponsor: J. Morita USA, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2007-08-17
Classification & Regulation
This clearance is catalogued under FDA product code EKX and 21 CFR 872.4200, within the Dental review panel as a Class I device.