Clearance Summary
INTRA LUX HEAD 3 LDSY received FDA 510(k) clearance under submission number K092446, sponsored by Kaltenbach & Voigt GmbH & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-11-03.
- Submission: K092446
- Applicant / Sponsor: Kaltenbach & Voigt GmbH & Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2009-11-03
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.