Clearance Summary
SHINER STRESS DIRECTING ATTACHMENT received FDA 510(k) clearance under submission number K863243, sponsored by Js & R - R & D Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1986-10-30.
- Submission: K863243
- Applicant / Sponsor: Js & R - R & D Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3165
- Decision date: 1986-10-30
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.