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FDA 510(k)

VOCO PROFLUORID VARNISH

K-Number: K080814 · 2008-07-24

ApplicantVoco GmbH
Decision Date2008-07-24
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VOCO PROFLUORID VARNISH is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2008-07-24 under 510(k) number K080814. 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 VOCO PROFLUORID VARNISH?

VOCO PROFLUORID VARNISH is a medical device that received FDA 510(k) clearance on 2008-07-24. The listed applicant is Voco GmbH. The 510(k) number is K080814.

When did VOCO PROFLUORID VARNISH receive FDA 510(k) clearance?

VOCO PROFLUORID VARNISH received FDA 510(k) clearance on 2008-07-24, under 510(k) number K080814.

Who is the listed applicant for VOCO PROFLUORID VARNISH?

The FDA 510(k) record lists Voco GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VOCO PROFLUORID VARNISH?

The FDA product code for VOCO PROFLUORID VARNISH is LBH.

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Other records listing Voco GmbH 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.

K252073VOCO Profluorid Varnish + BioMinK261357Grandio disc multicolorK252606Bifix Veneer LC, Bifix Veneer Try-InK251390MTA vptK251239GrandioSO UnlimitedK231817AlignerFlow LC

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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.

K262243Profisil FreeKettenbach GmbH & Co. KGK253052Fluoride 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.

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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