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510(k) K040098

Device
VARNISHAMERICA
Applicant
MEDICAL PRODUCTS LABORATORIES, INC.
510(k) number
K040098
Product code
LBH  
Decision
Substantially Equivalent (SESE)
Decision date
2004-02-04
Date received
2004-01-20
Regulation
872.3260
Classification name
Varnish, Cavity
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
ROBERT J MALERMAN
Address
9990 Global Rd. Philadelphia PA US 19115 19115

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LBH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252073VOCO Profluorid Varnish + BioMinVoco GmbH2026-05-01
K261404UltraEZUltradent Products, Inc.2026-04-30
K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd.2026-03-18
K250714FluoroDose VarnishCentrix, Inc.2025-11-21
K243777Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)Theodent, LLC2025-05-27
K241568CrystLCare™ PRO Biorestorative, Fluoride-PlusGreenMark Biomedical, Inc.2025-01-02
K242913Jasmate® ToothpasteJasberry Healthcare Private Limited2024-11-22
K233768Papacarie DuoElevate Oral Care2024-07-18
K231060ProMin Dental Desensitizing GelBelport Company, Inc., Gingi-Pak2024-06-13
K230333Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)Kettenbach GmbH & Co. KG2023-07-24
K222891Dental DesensitizerGuangzhou Beogene Biotech Co., Ltd.2023-05-25
K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment3M Espe Dental Products2023-05-10
K220419Apapro DesensitizerSangi Co., Ltd.2022-02-16
K200077BioMin Restore PlusDr. Collins, Inc.2020-11-06
K200614FiteBac Antimicrobial Cavity CleanserLargent Health, LLC2020-06-25

Legacy Summary#

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FDA Review#

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