Dental Barrier and Sleeves— 510(k) K242435

Name: FDA 510(k) clearance K242435
Creator: U.S. Food and Drug Administration
Published: 2024-10-18

Substantially Equivalent

Wellmed Dental Medical Supply Co., Ltd.

FDA 510(k) clearance K242435 for Dental Barrier and Sleeves, Substantially Equivalent on 2024-10-18. Applicant: Wellmed Dental Medical Supply Co., Ltd.. Device class: 2.

Clearance details

Applicant: Wellmed Dental Medical Supply Co., Ltd.
Product code: Code PEM
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2024-08-16
Decision date: 2024-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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