Clearance Summary
STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE received FDA 510(k) clearance under submission number K960719, sponsored by Dentalez Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1996-03-28.
- Submission: K960719
- Applicant / Sponsor: Dentalez Group
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1996-03-28
Classification & Regulation
This clearance is catalogued under FDA product code EFA and 21 CFR 872.4200, within the Dental review panel as a Class I device.