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FDA 510(k)

VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH

K-Number: K092141 · 2010-03-10

Applicant3M Espe Dental Products
Decision Date2010-03-10
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH is the device name listed in this FDA 510(k) record. The listed applicant is 3M Espe Dental Products. It received FDA 510(k) clearance on 2010-03-10 under 510(k) number K092141. 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 VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH?

VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH is a medical device that received FDA 510(k) clearance on 2010-03-10. The listed applicant is 3M Espe Dental Products. The 510(k) number is K092141.

When did VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH receive FDA 510(k) clearance?

VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH received FDA 510(k) clearance on 2010-03-10, under 510(k) number K092141.

Who is the listed applicant for VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH?

The FDA 510(k) record lists 3M Espe Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH?

The FDA product code for VANISH VARNISH, 5% SODIUM FLUORIDE WHITE 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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