Clearance Summary
ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES received FDA 510(k) clearance under submission number K900178, sponsored by Core-Vent 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 1990-05-31.
- Submission: K900178
- Applicant / Sponsor: Core-Vent Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6510
- Decision date: 1990-05-31
Classification & Regulation
This clearance is catalogued under FDA product code EFS and 21 CFR 872.6510, within the Dental review panel as a Class I device.