Clearance Summary
DENPAX received FDA 510(k) clearance under submission number K860058, sponsored by Nissho Iwai American 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 1986-03-12.
- Submission: K860058
- Applicant / Sponsor: Nissho Iwai American Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1986-03-12
Classification & Regulation
This clearance is catalogued under FDA product code EBR and 21 CFR 872.6640, within the Dental review panel as a Class I device.