Cleared Traditional

K151123 - Pac-Dent Barrier Sleeve

K151123 is an FDA 510(k) clearance for Pac-Dent Barrier Sleeve, manufactured by Pac-Dent International, Inc.. The device is a Class 2 Dental device with product code PEM cleared through the Traditional 510(k) pathway after a 310-day FDA review.

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

FDA 510(k) Submission Details - K151123

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.

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.