Clearance Summary
430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES received FDA 510(k) clearance under submission number K130455, sponsored by Dentalez Group, Stardental Division. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2013-09-25.
- Submission: K130455
- Applicant / Sponsor: Dentalez Group, Stardental Division
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2013-09-25
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.