Clearance Summary
FIBRELIGHT ILLUMINATING ORAL RETRACTORS received FDA 510(k) clearance under submission number K854711, sponsored by Downs Surgical , 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 1986-02-25.
- Submission: K854711
- Applicant / Sponsor: Downs Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1986-02-25
Classification & Regulation
This clearance is catalogued under FDA product code EIG and 21 CFR 872.4565, within the Dental review panel as a Class I device.