Clearance Summary
OBTURATION GUTTA received FDA 510(k) clearance under submission number K822464, sponsored by U.S. Shizai 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 1982-11-03.
- Submission: K822464
- Applicant / Sponsor: U.S. Shizai Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1982-11-03
Classification & Regulation
This clearance is catalogued under FDA product code EKA and 21 CFR 872.4565, within the Dental review panel as a Class I device.