Clearance Summary
Star E900 Handpiece Series received FDA 510(k) clearance under submission number K240183, sponsored by Dentalez, Inc., 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 2024-09-19.
- Submission: K240183
- Applicant / Sponsor: Dentalez, Inc., Stardental Division
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2024-09-19
Classification & Regulation
This clearance is catalogued under FDA product code EGS and 21 CFR 872.4200, within the Dental review panel as a Class I device.