Cleared Traditional

K190949 - ScanX Barrier Envelopes

K190949 is the FDA 510(k) clearance for ScanX Barrier Envelopes by Air Techniques, Inc.. It is a Class 2 General & Plastic Surgery device (product code PEM) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K190949 · Air Techniques, Inc. · General & Plastic Surgery device
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Jul 2019
Decision
106d
Days
Class 2
Risk

K190949 is an FDA 510(k) clearance for the ScanX Barrier Envelopes. Classified as Dental Barriers And Sleeves (product code PEM), Class II - Special Controls.

Submitted by Air Techniques, Inc. (Melville, US). The FDA issued a Cleared decision on July 26, 2019 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4370 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Air Techniques, Inc. devices

Submission Details

510(k) Number K190949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PEM Dental Barriers And Sleeves
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - PEM Dental Barriers And Sleeves

All 11
Devices cleared under the same product code (PEM) and FDA review panel - the closest regulatory comparables to K190949.
Plasdent Disposable Barrier Sleeves and Barrier Film
K201604 · Plasdent Corporation · Dec 2020
Barrier Sleeves
K191448 · Ivoclar Vivadent, AG · Oct 2019
BH Medical Dental Barrier Sleeves and Barrier Film
K190484 · Bh Medical Products Co., Ltd. · Sep 2019
UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
K183263 · Unipack Medical Corporation · Jun 2019
Disposable Barrier Sleeves and Covers
K160232 · Dentsply International, Inc. · Jun 2016