Clearance Summary
ZEN CORDLESS PROPHY SYSTEM received FDA 510(k) clearance under submission number K101612, sponsored by Discus Dental, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2010-06-30.
- Submission: K101612
- Applicant / Sponsor: Discus Dental, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2010-06-30
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.