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FDA 510(k)

BH Medical Dental Barrier Sleeves and Barrier Film

K-Number: K190484 · 2019-09-10

ApplicantBh Medical Products Co., Ltd.
Decision Date2019-09-10
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BH Medical Dental Barrier Sleeves and Barrier Film is a medical device manufactured by Bh Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2019-09-10 under approval number K190484. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BH Medical Dental Barrier Sleeves and Barrier Film?

BH Medical Dental Barrier Sleeves and Barrier Film is a medical device that received FDA 510(k) clearance on 2019-09-10. It is manufactured by Bh Medical Products Co., Ltd.. The 510(k) number is K190484.

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

BH Medical Dental Barrier Sleeves and Barrier Film received FDA 510(k) clearance on 2019-09-10, under approval number K190484.

What company makes BH Medical Dental Barrier Sleeves and Barrier Film?

BH Medical Dental Barrier Sleeves and Barrier Film is manufactured by Bh Medical Products Co., Ltd..

What is the FDA product code for BH Medical Dental Barrier Sleeves and Barrier Film?

The FDA product code for BH Medical Dental Barrier Sleeves and Barrier Film is PEM.

Related Clinical Trials

NCT07613658 3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition. NOT_YET_RECRUITING NCT06308640 Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography ACTIVE_NOT_RECRUITING NCT06948162 Exploration of the Utility of Dental-dedicated MRI for Dentistry RECRUITING NCT06692582 Electrolysed Saline Rinse as an Adjunct for Treatment of Chronic Periodontitis RECRUITING NCT06960161 Exploring the Use of Phototherapy to Improve CPAP Compliance RECRUITING NCT05171231 Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery COMPLETED

Related PubMed Literature

PMID: 40774046 Strengthening Dental Materiovigilance: A Review of International Reporting Frameworks. International dental journal (2025)

Other Devices by Bh Medical Products Co., Ltd.

K172280BH Sterilization Pouch

Related Devices (Code: PEM)

K160232Disposable Barrier Sleeves and CoversDentsply International, Inc. K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmPac-Dent International, Inc. K163447Premium Plus Disposable Barrier SleevePremium Plus International Limited K191448Barrier SleevesIvoclar Vivadent, AG K190949ScanX Barrier EnvelopesAir Techniques, Inc. K183263UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier EnvelopeUnipack Medical Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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