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FDA 510(k)

FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH

K-Number: K090597 · 2009-03-16

ApplicantPascal Co., Inc.
Decision Date2009-03-16
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH is the device name listed in this FDA 510(k) record. The listed applicant is Pascal Co., Inc.. It received FDA 510(k) clearance on 2009-03-16 under 510(k) number K090597. 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 FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH?

FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH is a medical device that received FDA 510(k) clearance on 2009-03-16. The listed applicant is Pascal Co., Inc.. The 510(k) number is K090597.

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

FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH received FDA 510(k) clearance on 2009-03-16, under 510(k) number K090597.

Who is the listed applicant for FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH?

The FDA 510(k) record lists Pascal Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH?

The FDA product code for FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH is LBH.

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Other records listing Pascal Co., Inc. 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.

K102526BLO2X OXYGEN BLOCKERK040988ZIRCON-F PROPHYLAXIS PASTEK040661RADENT PROPHY PASTEK012889BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANTK030488FLUORILAQK912632OCCLUDE

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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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