Dental Barrier and Sleeves— 510(k) K250735

Name: FDA 510(k) clearance K250735
Creator: U.S. Food and Drug Administration
Published: 2025-06-10

Substantially Equivalent

Fomed Industries, Inc.

FDA 510(k) clearance K250735 for Dental Barrier and Sleeves, Substantially Equivalent on 2025-06-10. Applicant: Fomed Industries, Inc.. Device class: 2.

Clearance details

Applicant: Fomed Industries, Inc.
Product code: Code PEM
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2025-03-11
Decision date: 2025-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qian Jing City, 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.