Cleared Traditional

Dental Barrier and Sleeves

K242435 · Wellmed Dental Medical Supply Co., Ltd. · Dental

Oct 2024

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K242435 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 Wellmed Dental Medical Supply Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 18, 2024, 63 days after receiving the submission on August 16, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K242435 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 2024
Decision Date	October 18, 2024
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement

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.