Clearance Summary
SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE received FDA 510(k) clearance under submission number K131906, sponsored by Satelec - Acteon Group. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2014-04-11.
- Submission: K131906
- Applicant / Sponsor: Satelec - Acteon Group
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6070
- Decision date: 2014-04-11
Classification & Regulation
This clearance is catalogued under FDA product code EBZ and 21 CFR 872.6070, within the Dental review panel as a Class II device.