Clearance Summary
I-ENDO DUAL received FDA 510(k) clearance under submission number K111623, sponsored by Satelec - Acteon Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-01-10.
- Submission: K111623
- Applicant / Sponsor: Satelec - Acteon Group
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2012-01-10
Classification & Regulation
This clearance is catalogued under FDA product code EBW and 21 CFR 872.4200, within the Dental review panel as a Class I device.