Clearance Summary
FD3500 (DENTAL CHAIR) received FDA 510(k) clearance under submission number K893889, sponsored by Oriola OY Finndent. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-08-15.
- Submission: K893889
- Applicant / Sponsor: Oriola OY Finndent
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6250
- Decision date: 1989-08-15
Classification & Regulation
This clearance is catalogued under FDA product code KLC and 21 CFR 872.6250, within the Dental review panel as a Class I device.