Clearance Summary
DENTAL HANDPIECE received FDA 510(k) clearance under submission number K840690, sponsored by Pen-Med Technology, 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 1984-04-25.
- Submission: K840690
- Applicant / Sponsor: Pen-Med Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1984-04-25
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.