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FDA 510(k)

VARNISHAMERICA

K-Number: K040098 · 2004-02-04

ApplicantMedical Products Laboratories, Inc.
Decision Date2004-02-04
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VARNISHAMERICA is the device name listed in this FDA 510(k) record. The listed applicant is Medical Products Laboratories, Inc.. It received FDA 510(k) clearance on 2004-02-04 under 510(k) number K040098. 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 VARNISHAMERICA?

VARNISHAMERICA is a medical device that received FDA 510(k) clearance on 2004-02-04. The listed applicant is Medical Products Laboratories, Inc.. The 510(k) number is K040098.

When did VARNISHAMERICA receive FDA 510(k) clearance?

VARNISHAMERICA received FDA 510(k) clearance on 2004-02-04, under 510(k) number K040098.

Who is the listed applicant for VARNISHAMERICA?

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

What is the FDA product code for VARNISHAMERICA?

The FDA product code for VARNISHAMERICA is LBH.

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Other records listing Medical Products Laboratories, 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.

K844572PRE-KLENE ENAMEL CLEANER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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