Dental Barrier and Sleeves— 510(k) K250606

Name: FDA 510(k) clearance K250606
Creator: U.S. Food and Drug Administration
Published: 2025-05-29

Substantially Equivalent

Yueying Medical Instruments (Langfang) Co., Ltd.

FDA 510(k) clearance K250606 for Dental Barrier and Sleeves, Substantially Equivalent on 2025-05-29. Applicant: Yueying Medical Instruments (Langfang) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Yueying Medical Instruments (Langfang) Co., Ltd.
Product code: Code PEM
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2025-02-28
Decision date: 2025-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langfang, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code PEM

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K261956 — Dental Barriers and Sleeves (AB0006)2026-09-08
K250735 — Dental Barrier and Sleeves2025-06-10
K242435 — Dental Barrier and Sleeves2024-10-18
K233918 — Dental Barrier and Sleeves2024-05-09
K220662 — Disposable Barrier Sleeves2022-05-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.