Cleared Traditional

K160232 - Disposable Barrier Sleeves and Covers

K160232 is an FDA 510(k) clearance for Disposable Barrier Sleeves and Covers, manufactured by Dentsply International, Inc.. The device is a Class 2 Dental device with product code PEM cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K160232 · Dentsply International, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
127d
Days
Class 2
Risk

K160232 is an FDA 510(k) clearance for the Disposable Barrier Sleeves and Covers. Classified as Dental Barriers And Sleeves (product code PEM), Class II - Special Controls.

Submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on June 7, 2016 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 878.4370 - the FDA dental device regulatory 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentsply International, Inc. devices

FDA 510(k) Submission Details - K160232

510(k) Number K160232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2016
Decision Date June 07, 2016
Days to Decision 127 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 127d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PEM Device Classification - Class 2, Special Controls

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 Dental devices follow this clearance model.

Regulatory Peers - PEM Dental Barriers And Sleeves

All 14
Devices cleared under the same product code (PEM) and FDA review panel - the closest regulatory comparables to K160232.
ScanX Barrier Envelopes
K190949 · Air Techniques, Inc. · Jul 2019
UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
K183263 · Unipack Medical Corporation · Jun 2019
Premium Plus Disposable Barrier Sleeve
K163447 · Premium Plus International Limited · Jun 2017
Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
K151123 · Pac-Dent International, Inc. · Mar 2016
TIDISHEILD
K132953 · Tidi Products,Llc · Feb 2014