Clearance Summary
AEU-26L ELCTRONIC ENDODONTIC SYSTEM received FDA 510(k) clearance under submission number K111078, sponsored by Aseptico, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2011-06-14.
- Submission: K111078
- Applicant / Sponsor: Aseptico, Inc.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2011-06-14
Classification & Regulation
This clearance is catalogued under FDA product code EKX and 21 CFR 872.4200, within the Dental review panel as a Class I device.