Clearance Summary
TRADITION P, PUSH BUTTON HANDPIECE received FDA 510(k) clearance under submission number K963050, sponsored by Midwest Dental Products 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 1996-10-11.
- Submission: K963050
- Applicant / Sponsor: Midwest Dental Products Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1996-10-11
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.