Clearance Summary
OPTI-SHIELD received FDA 510(k) clearance under submission number K924089, sponsored by Fuji Optical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1993-03-31.
- Submission: K924089
- Applicant / Sponsor: Fuji Optical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1993-03-31
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.