Clearance Summary
OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR received FDA 510(k) clearance under submission number K971063, sponsored by King Dental Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-06-03.
- Submission: K971063
- Applicant / Sponsor: King Dental Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6250
- Decision date: 1997-06-03
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.