Clearance Summary
76 ELW BITE CHECKER SILICONE received FDA 510(k) clearance under submission number K851469, sponsored by G-C Intl. 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 1985-05-01.
- Submission: K851469
- Applicant / Sponsor: G-C Intl. Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 1985-05-01
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.