BH Medical Dental Barrier Sleeves and Barrier Film
K-Number: K190484 · 2019-09-10
Device Summary
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. The listed applicant is Bh Medical Products Co., Ltd.. The 510(k) number is K190484.
When did BH Medical Dental Barrier Sleeves and Barrier Film receive FDA 510(k) clearance?
BH Medical Dental Barrier Sleeves and Barrier Film received FDA 510(k) clearance on 2019-09-10, under 510(k) number K190484.
Who is the listed applicant for BH Medical Dental Barrier Sleeves and Barrier Film?
The FDA 510(k) record lists Bh Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
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.
Other records listing Bh Medical Products Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: PEM)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.