# K233918: Dental Barrier and Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Yongqing Huaguan Dental Instruments Factory
- Decided: May 9, 2024 after 148 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.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190484: BH Medical Dental Barrier Sleeves and Barrier Film, Bh Medical Products Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K250606: Dental Barrier and Sleeves (2025), 1 descendant of its own
- K262073: Hygienic Protective Bite Cover (2207-010-50) (2026), 0 descendants of its own

## Indications for use
Dental Barrier and Sleeves are intended to be used 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 model numbers and descriptions in 510(k) Summary.

Source page: https://510kreport.com/device/K233918
Methodology: https://510kreport.com/methodology