Cleared Traditional

K163447 - Premium Plus Disposable Barrier Sleeve

K163447 is an FDA 510(k) clearance for Premium Plus Disposable Barrier Sleeve, manufactured by Premium Plus International Limited. The device is a Class 2 Dental device with product code PEM cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K163447 · Premium Plus International Limited · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
194d
Days
Class 2
Risk

K163447 is an FDA 510(k) clearance for the Premium Plus Disposable Barrier Sleeve. Classified as Dental Barriers And Sleeves (product code PEM), Class II - Special Controls.

Submitted by Premium Plus International Limited (Hong Kong, CN). The FDA issued a Cleared decision on June 20, 2017 after a review of 194 days - an extended review cycle.

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.

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FDA 510(k) Submission Details - K163447

510(k) Number K163447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2016
Decision Date June 20, 2017
Days to Decision 194 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 127d · This submission: 194d
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 12
Devices cleared under the same product code (PEM) and FDA review panel - the closest regulatory comparables to K163447.
BH Medical Dental Barrier Sleeves and Barrier Film
K190484 · Bh Medical Products Co., Ltd. · Sep 2019
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
Disposable Barrier Sleeves and Covers
K160232 · Dentsply International, Inc. · Jun 2016