# K191448: Barrier Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, AG
- Decided: Oct 8, 2019 after 130 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.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160232: Disposable Barrier Sleeves and Covers, Dentsply International, Inc. (2016) Summary page 4.

## Most influential descendants
- K211026: Minitube Dentasleeve Protective Barrier Sleeves (2021), 0 descendants of its own

## Indications for use
Barrier Sleeves 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.

Source page: https://510kreport.com/device/K191448
Methodology: https://510kreport.com/methodology