Clearance Summary
DYNA SYSTEM received FDA 510(k) clearance under submission number K855167, sponsored by Parker Laboratories, 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 1986-03-04.
- Submission: K855167
- Applicant / Sponsor: Parker Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3165
- Decision date: 1986-03-04
Classification & Regulation
This clearance is catalogued under FDA product code EGG and 21 CFR 872.3165, within the Dental review panel as a Class I device.