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Dental Barrier and Sleeves

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K250735

by Fomed Industries Inc

Identifiers

510(k) Number
K250735 FDA 510(k)
FDA Product Code
PEM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4370 FDA 510(k)
Regulation Number
878.4370 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Dental Barrier and Sleeves is a Class II medical device designed to provide a protective barrier during dental procedures. These barriers are intended to isolate the dental operatory area, preventing contamination of the patient’s oral cavity and protecting dental professionals from splatter and aerosols generated during treatments such as drilling, polishing, or restorative work.

Supplied as single-use sterile items, these barriers are used in dental clinics and offices to enhance infection control. They are manufactured in various sizes and configurations, as indicated by the listed FEI numbers, and comply with FDA 510(k) clearance under regulation number 878.4370. The device is intended for general dental applications and is regulated under the Medical Specialty category of General Plastic Surgery.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fomed Industries Inc
FDA Applicant
Fomed Industries, Inc.

Sources (2)

  • FDA 510(k) K250735 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 29, 2026