FDA.reportPublic FDA data

510(k) K230333

Device
Profisil 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 (1
Applicant
Kettenbach GmbH & Co. KG
510(k) number
K230333
Product code
LBH
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-24
Date received
2023-02-07
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
No

Applicant Contact#

Contact
Katja Simon
Address
Im Heerfeld 7 Eschenburg DE 35713 35713

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
K241489ReminGelInter-Med, Inc.2025-01-08
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
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