# K262073: Hygienic Protective Bite Cover (2207-010-50)

- Pathway: 510(k) (Traditional)
- Applicant: Dürr Dental SE
- Decided: Sep 17, 2026 after 87 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: 5 generations back to K132953 (2014). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250606: Dental Barrier and Sleeves, Yueying Medical Instruments (Langfang) Co., Ltd. (2025) Summary page 6.

## Indications for use
Hygienic protective covers serve as hygienic barrier between dental instruments, equipment, accessories, and patient during use. The device is non-sterile and intended for single patient use only.

Source page: https://510kreport.com/device/K262073
Methodology: https://510kreport.com/methodology