Cleared Traditional

Dental Barrier and Sleeves

K250735 · Fomed Industries, Inc. · Dental

Jun 2025

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K250735 is an FDA 510(k) clearance for the Dental Barrier and Sleeves, a Dental Barriers And Sleeves (Class II — Special Controls, product code PEM), submitted by Fomed Industries, Inc. (Qian Jing City, CN). The FDA issued a Cleared decision on June 10, 2025, 91 days after receiving the submission on March 11, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K250735 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 2025
Decision Date	June 10, 2025
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	PEM — Dental Barriers And Sleeves
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4370
Definition	Intended To Serve As A Disposable Barrier For Dental Instruments To Reduce The Risk Of Cross Contamination Between Dental Patients.