Clearance Summary
Plasdent Disposable Barrier Sleeves and Barrier Film received FDA 510(k) clearance under submission number K201604, sponsored by Plasdent Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2020-12-23.
- Submission: K201604
- Applicant / Sponsor: Plasdent Corporation
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 2020-12-23
Classification & Regulation
This clearance is catalogued under FDA product code PEM and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.