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FDA 510(k)

Dental Desensitizer

K-Number: K222891 · 2023-05-25

ApplicantGuangzhou Beogene Biotech Co., Ltd.
Decision Date2023-05-25
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Desensitizer is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Beogene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K222891. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Desensitizer?

Dental Desensitizer is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Guangzhou Beogene Biotech Co., Ltd.. The 510(k) number is K222891.

When did Dental Desensitizer receive FDA 510(k) clearance?

Dental Desensitizer received FDA 510(k) clearance on 2023-05-25, under 510(k) number K222891.

Who is the listed applicant for Dental Desensitizer?

The FDA 510(k) record lists Guangzhou Beogene Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Desensitizer?

The FDA product code for Dental Desensitizer is LBH.

Related Devices (Code: LBH)

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.

K253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd.K252073VOCO Profluorid Varnish + BioMinVoco GmbHK261404UltraEZUltradent Products, Inc.K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd.K250714FluoroDose VarnishCentrix, Inc.K243777Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)Theodent, LLC

Official Source

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

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