# K160232: Disposable Barrier Sleeves and Covers

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: Jun 7, 2016 after 127 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: 1 generation back to K132953 (2014). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132953: Tidisheild, Tidi Products,Llc (2014) Summary page 7.

## Most influential descendants
- K191448: Barrier Sleeves (2019), 1 descendant of its own
- K261956: Dental Barriers and Sleeves (AB0006) (2026), 0 descendants of its own
- K211026: Minitube Dentasleeve Protective Barrier Sleeves (2021), 0 descendants of its own

## Indications for use
Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only. See the attached table for the product names, trade names and model numbers.

Source page: https://510kreport.com/device/K160232
Methodology: https://510kreport.com/methodology