# K261956: Dental Barriers and Sleeves (AB0006)

- Pathway: 510(k) (Traditional)
- Applicant: ANI Co., Ltd.
- Decided: Sep 8, 2026 after 89 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)
- K132953: Tidisheild, Tidi Products,Llc (2014) Summary page 6.
- K160232: Disposable Barrier Sleeves and Covers, Dentsply International, Inc. (2016) Summary page 7.

## Indications for use
The Dental Barriers and Sleeves are intended to be used as a barrier to cover dental instruments. This device is non-sterile and is intended for single patient use only.

Source page: https://510kreport.com/device/K261956
Methodology: https://510kreport.com/methodology