Clearance Summary
DENE BRIDGE received FDA 510(k) clearance under submission number K903672, sponsored by Dirotian Pty. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1990-12-05.
- Submission: K903672
- Applicant / Sponsor: Dirotian Pty. , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3600
- Decision date: 1990-12-05
Classification & Regulation
This clearance is catalogued under FDA product code EKO and 21 CFR 872.3600, within the Dental review panel as a Class II device.