Clearance Summary
Maxima Electric System received FDA 510(k) clearance under submission number K180845, sponsored by Handpiece Headquarters - Hpr, 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 2019-07-25.
- Submission: K180845
- Applicant / Sponsor: Handpiece Headquarters - Hpr, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2019-07-25
Classification & Regulation
This clearance is catalogued under FDA product code EBW and 21 CFR 872.4200, within the Dental review panel as a Class I device.