# K211026: Minitube Dentasleeve Protective Barrier Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Minitube AB
- Decided: Aug 3, 2021 after 119 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: 3 generations back to K132953 (2014). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191448: Barrier Sleeves, Ivoclar Vivadent, AG (2019) Summary page 5.

## Indications for use
Minitube Dentasleeve Protective 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/K211026
Methodology: https://510kreport.com/methodology