Cleared Traditional

K151123 - Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K151123 · Pac-Dent International, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
310d
Days
Class 2
Risk

K151123 is an FDA 510(k) clearance for the Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film. Classified as Dental Barriers And Sleeves (product code PEM), Class II - Special Controls.

Submitted by Pac-Dent International, Inc. (Brea, US). The FDA issued a Cleared decision on March 3, 2016 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Pac-Dent International, Inc. devices

Submission Details

510(k) Number K151123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2015
Decision Date March 03, 2016
Days to Decision 310 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
183d slower than avg
Panel avg: 127d · This submission: 310d
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 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 K151123.
Dental Barrier and Sleeves
K250735 · Fomed Industries, Inc. · Jun 2025
Dental Barrier and Sleeves
K250606 · Yueying Medical Instruments (Langfang) Co., Ltd. · May 2025
Dental Barrier and Sleeves
K242435 · Wellmed Dental Medical Supply Co., Ltd. · Oct 2024
Dental Barrier and Sleeves
K233918 · Yongqing Huaguan Dental Instruments Factory · May 2024
Disposable Barrier Sleeves
K220662 · Premium Plus (Dongguan) Limited · May 2022
Minitube Dentasleeve Protective Barrier Sleeves
K211026 · Minitube AB · Aug 2021