# K201604: Plasdent Disposable Barrier Sleeves and Barrier Film

- Pathway: 510(k) (Traditional)
- Applicant: Plasdent Corporation
- Decided: Dec 23, 2020 after 191 days
- Product code: PEM (Dental Barriers And Sleeves)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K132953 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151123: Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier Film, Pac-Dent International, Inc. (2016) Summary page 6.

## Indications for use
Plasdent Disposable Barrier Sleeves and Barrier Film are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient one time use only.

Source page: https://510kreport.com/device/K201604
Methodology: https://510kreport.com/methodology