Clearance Summary
POLY-LITE MODEL 1000 received FDA 510(k) clearance under submission number K954061, sponsored by Pro-Den Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-09-21.
- Submission: K954061
- Applicant / Sponsor: Pro-Den Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6070
- Decision date: 1995-09-21
Classification & Regulation
This clearance is catalogued under FDA product code EBZ and 21 CFR 872.6070, within the Dental review panel as a Class II device.