Clearance Summary
ID-TAB received FDA 510(k) clearance under submission number K913160, sponsored by Nix Co. , 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 1991-09-06.
- Submission: K913160
- Applicant / Sponsor: Nix Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.1905
- Decision date: 1991-09-06
Classification & Regulation
This clearance is catalogued under FDA product code EGZ and 21 CFR 872.1905, within the Dental review panel as a Class I device.