Clearance Summary
SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST received FDA 510(k) clearance under submission number K132356, sponsored by Scican GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2014-01-31.
- Submission: K132356
- Applicant / Sponsor: Scican GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2014-01-31
Classification & Regulation
This clearance is catalogued under FDA product code EGS and 21 CFR 872.4200, within the Dental review panel as a Class I device.