Cleared Traditional

Barrier Sleeves

K191448 · Ivoclar Vivadent, AG · Dental

Oct 2019

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K191448 is an FDA 510(k) clearance for the Barrier Sleeves, a Dental Barriers And Sleeves (Class II — Special Controls, product code PEM), submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on October 8, 2019, 130 days after receiving the submission on May 31, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K191448 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2019
Decision Date	October 08, 2019
Days to Decision	130 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.