Clearance Summary
SAF (SELF ADJUSTING FILE) received FDA 510(k) clearance under submission number K092933, sponsored by Redent-Nova , 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 2010-01-14.
- Submission: K092933
- Applicant / Sponsor: Redent-Nova , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2010-01-14
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.