Cleared Traditional

K201604 - Plasdent Disposable Barrier Sleeves and...

K201604 is an FDA 510(k) clearance for Plasdent Disposable Barrier Sleeves and..., manufactured by Plasdent Corporation. The device is a Class 2 General & Plastic Surgery device with product code PEM cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K201604 · Plasdent Corporation · General & Plastic Surgery device
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Dec 2020
Decision
191d
Days
Class 2
Risk

K201604 is an FDA 510(k) clearance for the Plasdent Disposable Barrier Sleeves and Barrier Film. Classified as Dental Barriers And Sleeves (product code PEM), Class II - Special Controls.

Submitted by Plasdent Corporation (Pomona, US). The FDA issued a Cleared decision on December 23, 2020 after a review of 191 days - an extended review cycle.

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 Plasdent Corporation devices

FDA 510(k) Submission Details - K201604

510(k) Number K201604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2020
Decision Date December 23, 2020
Days to Decision 191 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
76d slower than avg
Panel avg: 115d · This submission: 191d
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 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 K201604.
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
Barrier Sleeves
K191448 · Ivoclar Vivadent, AG · Oct 2019
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