Clearance Summary
TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE) received FDA 510(k) clearance under submission number K120218, sponsored by Palm Beach Dental Supply D/B/A Tek USA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-06-29.
- Submission: K120218
- Applicant / Sponsor: Palm Beach Dental Supply D/B/A Tek USA
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2012-06-29
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.