Clearance Summary
PS System received FDA 510(k) clearance under submission number K211721, sponsored by Inter-Med, 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 2021-12-02.
- Submission: K211721
- Applicant / Sponsor: Inter-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2021-12-02
Classification & Regulation
This clearance is catalogued under FDA product code NYL and 21 CFR 872.4200, within the Dental review panel as a Class I device.