Clearance Summary
E-STATIS 40 SYSTEM received FDA 510(k) clearance under submission number K090937, sponsored by Scican , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-07-24.
- Submission: K090937
- Applicant / Sponsor: Scican , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2009-07-24
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.