Clearance Summary
INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH received FDA 510(k) clearance under submission number K854765, sponsored by C&C Systems, 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 1986-06-13.
- Submission: K854765
- Applicant / Sponsor: C&C Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3285
- Decision date: 1986-06-13
Classification & Regulation
This clearance is catalogued under FDA product code EHP and 21 CFR 872.3285, within the Dental review panel as a Class I device.