Cleared Traditional

Disposable Barrier Sleeves

K220662 · Premium Plus (Dongguan) Limited · Dental

May 2022

Decision

65d

Days

Class 2

Risk

About This 510(k) Submission

K220662 is an FDA 510(k) clearance for the Disposable Barrier Sleeves, a Dental Barriers And Sleeves (Class II — Special Controls, product code PEM), submitted by Premium Plus (Dongguan) Limited (Dongguan, CN). The FDA issued a Cleared decision on May 11, 2022, 65 days after receiving the submission on March 7, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K220662 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 07, 2022
Decision Date	May 11, 2022
Days to Decision	65 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.