Clearance Summary
PRO-SCOPE MODEL # PS-4000 received FDA 510(k) clearance under submission number K922942, 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 1993-09-10.
- Submission: K922942
- Applicant / Sponsor: Pro-Den Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1993-09-10
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.