Clearance Summary
Maxima PRO 45L received FDA 510(k) clearance under submission number K141576, sponsored by Kavo DO Brasil Industria E Comercio Ltda. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-05-04.
- Submission: K141576
- Applicant / Sponsor: Kavo DO Brasil Industria E Comercio Ltda
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2015-05-04
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.