Clearance Summary
GINGITRACT received FDA 510(k) clearance under submission number K771973, sponsored by Den-Mat 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 1977-11-07.
- Submission: K771973
- Applicant / Sponsor: Den-Mat Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1977-11-07
Classification & Regulation
This clearance is catalogued under FDA product code EIG and 21 CFR 872.4565, within the Dental review panel as a Class I device.