Clearance Summary
SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER received FDA 510(k) clearance under submission number K103753, sponsored by Sirona Dental Systems GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2011-02-15.
- Submission: K103753
- Applicant / Sponsor: Sirona Dental Systems GmbH
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2011-02-15
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.