Cleared Traditional

BH Medical Dental Barrier Sleeves and Barrier Film (K190484) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190484 · Bh Medical Products Co., Ltd. · General & Plastic Surgery device
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Sep 2019
Decision
195d
Days
Class 2
Risk

K190484 is an FDA 510(k) clearance for the BH Medical Dental Barrier Sleeves and Barrier Film. Classified as Dental Barriers And Sleeves (product code PEM), Class II - Special Controls.

Submitted by Bh Medical Products Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on September 10, 2019 after a review of 195 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 Bh Medical Products Co., Ltd. devices

Submission Details

510(k) Number K190484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2019
Decision Date September 10, 2019
Days to Decision 195 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
80d slower than avg
Panel avg: 115d · This submission: 195d
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 General & Plastic Surgery 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 K190484.
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