Cleared Traditional

Dental Barrier and Sleeves

K233918 · Yongqing Huaguan Dental Instruments Factory · Dental

May 2024

Decision

148d

Days

Class 2

Risk

About This 510(k) Submission

K233918 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 Yongqing Huaguan Dental Instruments Factory (Langfang, CN). The FDA issued a Cleared decision on May 9, 2024, 148 days after receiving the submission on December 13, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K233918 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2023
Decision Date	May 09, 2024
Days to Decision	148 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.