Clearance Summary
T1/T2/T3 TURBINE FAMILY received FDA 510(k) clearance under submission number K131319, sponsored by Sirona Dental Systems GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2014-05-30.
- Submission: K131319
- Applicant / Sponsor: Sirona Dental Systems GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2014-05-30
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.