Clearance Summary
DEN-MAT PORETCH (PORCELAIN ETCHANT) received FDA 510(k) clearance under submission number K875351, 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 1988-03-18.
- Submission: K875351
- Applicant / Sponsor: Den-Mat Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3920
- Decision date: 1988-03-18
Classification & Regulation
This clearance is catalogued under FDA product code ELL and 21 CFR 872.3920, within the Dental review panel as a Class II device.