Clearance Summary
H-TYPE BRIDGE REMOVER received FDA 510(k) clearance under submission number K842026, sponsored by Higa Manufacturing , 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 1984-07-11.
- Submission: K842026
- Applicant / Sponsor: Higa Manufacturing , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1984-07-11
Classification & Regulation
This clearance is catalogued under FDA product code EIS and 21 CFR 872.4565, within the Dental review panel as a Class I device.