Cleared Traditional

ScanX Barrier Envelopes

K190949 · Air Techniques, Inc. · General & Plastic Surgery

Jul 2019

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K190949 is an FDA 510(k) clearance for the ScanX Barrier Envelopes, a Dental Barriers And Sleeves (Class II — Special Controls, product code PEM), submitted by Air Techniques, Inc. (Melville, US). The FDA issued a Cleared decision on July 26, 2019, 106 days after receiving the submission on April 11, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K190949 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 2019
Decision Date	July 26, 2019
Days to Decision	106 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
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.