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FDA 510(k)

DURAGARD SODIUM FLUORIDE VARNISH

K-Number: K002581 · 2000-10-20

ApplicantSultan Dental Products, Ltd.
Decision Date2000-10-20
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DURAGARD SODIUM FLUORIDE VARNISH is the device name listed in this FDA 510(k) record. The listed applicant is Sultan Dental Products, Ltd.. It received FDA 510(k) clearance on 2000-10-20 under 510(k) number K002581. 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 DURAGARD SODIUM FLUORIDE VARNISH?

DURAGARD SODIUM FLUORIDE VARNISH is a medical device that received FDA 510(k) clearance on 2000-10-20. The listed applicant is Sultan Dental Products, Ltd.. The 510(k) number is K002581.

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

DURAGARD SODIUM FLUORIDE VARNISH received FDA 510(k) clearance on 2000-10-20, under 510(k) number K002581.

Who is the listed applicant for DURAGARD SODIUM FLUORIDE VARNISH?

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

What is the FDA product code for DURAGARD SODIUM FLUORIDE VARNISH?

The FDA product code for DURAGARD SODIUM 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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