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FDA 510(k)

FiteBac Antimicrobial Cavity Cleanser

K-Number: K200614 · 2020-06-25

ApplicantLargent Health, LLC
Decision Date2020-06-25
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FiteBac Antimicrobial Cavity Cleanser is the device name listed in this FDA 510(k) record. The listed applicant is Largent Health, LLC. It received FDA 510(k) clearance on 2020-06-25 under 510(k) number K200614. 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 FiteBac Antimicrobial Cavity Cleanser?

FiteBac Antimicrobial Cavity Cleanser is a medical device that received FDA 510(k) clearance on 2020-06-25. The listed applicant is Largent Health, LLC. The 510(k) number is K200614.

When did FiteBac Antimicrobial Cavity Cleanser receive FDA 510(k) clearance?

FiteBac Antimicrobial Cavity Cleanser received FDA 510(k) clearance on 2020-06-25, under 510(k) number K200614.

Who is the listed applicant for FiteBac Antimicrobial Cavity Cleanser?

The FDA 510(k) record lists Largent Health, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FiteBac Antimicrobial Cavity Cleanser?

The FDA product code for FiteBac Antimicrobial Cavity Cleanser is LBH.

Other records listing Largent Health, LLC 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.

K210115FiteBac CC OrthoSealK190271FiteBac Cavity Cleanser

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.

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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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