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FDA 510(k)

FLUORIDE VARNISH

K-Number: K031932 · 2003-09-15

ApplicantDentsply Intl.
Decision Date2003-09-15
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLUORIDE VARNISH is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2003-09-15 under 510(k) number K031932. 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 FLUORIDE VARNISH?

FLUORIDE VARNISH is a medical device that received FDA 510(k) clearance on 2003-09-15. The listed applicant is Dentsply Intl.. The 510(k) number is K031932.

When did FLUORIDE VARNISH receive FDA 510(k) clearance?

FLUORIDE VARNISH received FDA 510(k) clearance on 2003-09-15, under 510(k) number K031932.

Who is the listed applicant for FLUORIDE VARNISH?

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

What is the FDA product code for FLUORIDE VARNISH?

The FDA product code for FLUORIDE VARNISH is LBH.

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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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