BH Medical Dental Barrier Sleeves and Barrier Film

FDA 510(k) K190484 · Bh Medical Products Co., Ltd.

Substantially Equivalent

510(k) numberK190484

Submission

Device name
BH Medical Dental Barrier Sleeves and Barrier Film
Applicant
Bh Medical Products Co., Ltd.
Changzhou, CN
Received
February 27, 2019
Decision date
September 10, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PEM – Dental Barriers And Sleeves
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4370
Specialty
General, Plastic Surgery

Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.

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K211026Minitube Dentasleeve Protective Barrier SleevesPEM · Traditional Minitube AB08/03/2021SE
K201604Plasdent Disposable Barrier Sleeves and Barrier FilmPEM · Traditional Plasdent Corporation12/23/2020SE
K191448Barrier SleevesPEM · Traditional Ivoclar Vivadent, AG10/08/2019SE
K190949ScanX Barrier EnvelopesPEM · Traditional Air Techniques, Inc.07/26/2019SE

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Questions and answers

When was BH Medical Dental Barrier Sleeves and Barrier Film cleared by the FDA?

BH Medical Dental Barrier Sleeves and Barrier Film (K190484) received a 510(k) decision of Substantially Equivalent on September 10, 2019, 195 days after the submission was received.

What is the product code of K190484?

The FDA product code is PEM – Dental Barriers And Sleeves, a Class II (moderate risk) device regulated under 21 CFR 878.4370.