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FDA 510(k)

Apapro Desensitizer

K-Number: K220419 · 2022-02-16

ApplicantSangi Co., Ltd.
Decision Date2022-02-16
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Apapro Desensitizer is the device name listed in this FDA 510(k) record. The listed applicant is Sangi Co., Ltd.. It received FDA 510(k) clearance on 2022-02-16 under 510(k) number K220419. 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 Apapro Desensitizer?

Apapro Desensitizer is a medical device that received FDA 510(k) clearance on 2022-02-16. The listed applicant is Sangi Co., Ltd.. The 510(k) number is K220419.

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

Apapro Desensitizer received FDA 510(k) clearance on 2022-02-16, under 510(k) number K220419.

Who is the listed applicant for Apapro Desensitizer?

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

What is the FDA product code for Apapro Desensitizer?

The FDA product code for Apapro Desensitizer is LBH.

Other records listing Sangi 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.

K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)

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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