Cleared Traditional

Minitube Dentasleeve Protective Barrier Sleeves

K211026 · Minitube AB · Dental

Aug 2021

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K211026 is an FDA 510(k) clearance for the Minitube Dentasleeve Protective Barrier Sleeves, a Dental Barriers And Sleeves (Class II — Special Controls, product code PEM), submitted by Minitube AB (Tr?ngsviken, SE). The FDA issued a Cleared decision on August 3, 2021, 119 days after receiving the submission on April 6, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K211026 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2021
Decision Date	August 03, 2021
Days to Decision	119 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.