FDA.reportPublic FDA data

Dental coating, tooth-desensitizing, professional

Definition
A substance intended exclusively for professional use in a healthcare facility and designed to be applied to exposed dentine (resulting from enamel erosion, breakage, tooth restoration procedure or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and/or physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., solution, gel, mouth-rinse, resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. After application, this device cannot be reused.
GUDID devices
441
Last updated
2026-09-04 23:13:36

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850006606740Wonderful DentalRoses and Rubies, LLCFL010421012026-08-27
00850006606757Wonderful DentalRoses and Rubies, LLCFL020421012026-08-27
00850006606788Wonderful DentalRoses and Rubies, LLCFL010221012026-08-27
00850006606795Wonderful DentalRoses and Rubies, LLCFL020221012026-08-27
00850006606825Wonderful DentalRoses and Rubies, LLCFL010521012026-08-27
00850006606832Wonderful DentalRoses and Rubies, LLCFL020521012026-08-27
00850006606863Wonderful DentalRoses and Rubies, LLCFL010321012026-08-27
00850006606870Wonderful DentalRoses and Rubies, LLCFL020321012026-08-27
00850006606900Wonderful DentalRoses and Rubies, LLCFL010121012026-08-27
00850006606917Wonderful DentalRoses and Rubies, LLCFL020121012026-08-27
00850006606948Wonderful DentalRoses and Rubies, LLCFL020221012026-08-27
00850006606955Wonderful DentalRoses and Rubies, LLCFL020221012026-08-27
00850006606986Wonderful DentalRoses and Rubies, LLCFL020221012026-08-27
00197998150340Solventum™ Clinpro™Solventum US LLC7200M2026-08-23
00197998150371Solventum™ Clinpro™Solventum US LLC7200W2026-08-23
00197998150401Solventum™ Clinpro™Solventum US LLC7200FF2026-08-23
00197998150432Solventum™ Clinpro™Solventum US LLC7210M2026-08-23
00197998150463Solventum™ Clinpro™Solventum US LLC7210W2026-08-23
00197998150494Solventum™ Clinpro™Solventum US LLC7210FF2026-08-23
00197998150517Solventum™ Clinpro™Solventum US LLC7220SP2026-08-23
00197998219092Solventum™ Clinpro™Solventum US LLC7200W2026-08-23
00197998219108Solventum™ Clinpro™Solventum US LLC7200FF2026-08-23
00197998219115Solventum™ Clinpro™Solventum US LLC7210M2026-08-23
00197998219139Solventum™ Clinpro™Solventum US LLC7210W2026-08-23
00197998219146Solventum™ Clinpro™Solventum US LLC7210FF2026-08-23
00197998219214Solventum™ Clinpro™Solventum US LLC7200M2026-08-23
00197998486050Solventum™ Clinpro™Solventum US LLC7230B2026-08-23
DVIV550578AN1Fluor ProtectorIVOCLAR VIVADENT AKTIENGESELLSCHAFT550578AN2016-12-12
DVIV550579AN1Fluor ProtectorIVOCLAR VIVADENT AKTIENGESELLSCHAFT550579AN2016-12-12
E22122751VOCO Profluorid Varnish + BioMinVOCO GmbH22752026-07-26
00302730002171D-LISHYOUNG DENTAL MANUFACTURING I, LLC2124202022-10-16
00302730002188D-LISHYOUNG DENTAL MANUFACTURING I, LLC2124502022-10-16
00302730002195D-LISHYOUNG DENTAL MANUFACTURING I, LLC2134202022-10-16
00302730002201D-LISHYOUNG DENTAL MANUFACTURING I, LLC2134502022-10-16
00302730002218D-LISHYOUNG DENTAL MANUFACTURING I, LLC2144202022-10-16
00302730002225D-LISHYOUNG DENTAL MANUFACTURING I, LLC2144502022-10-16
00302730002232D-LISHYOUNG DENTAL MANUFACTURING I, LLC2184502022-10-16
00302730002249D-LISHYOUNG DENTAL MANUFACTURING I, LLC2954842022-10-16
00302730002256D-LISHYOUNG DENTAL MANUFACTURING I, LLC2956152022-10-16
00302730002263D-LISHYOUNG DENTAL MANUFACTURING I, LLC2957322022-10-16
00302730002270D-LISHYOUNG DENTAL MANUFACTURING I, LLC2957332022-10-16
00302730002294Varnish AmericaYOUNG DENTAL MANUFACTURING I, LLC07-01202022-10-16
00302730002409YoungYOUNG DENTAL MANUFACTURING I, LLC9993042022-10-16
00302730002423Varnish AmericaYOUNG DENTAL MANUFACTURING I, LLC07-01222022-10-16
00302730002430Varnish AmericaYOUNG DENTAL MANUFACTURING I, LLC07-01302022-10-16
00302730002447Varnish AmericaYOUNG DENTAL MANUFACTURING I, LLC07-01312022-10-16
00302730002454YoungYOUNG DENTAL MANUFACTURING I, LLC2957792022-10-16
00302730002461YoungYOUNG DENTAL MANUFACTURING I, LLC2957822022-10-16
00302730002478YoungYOUNG DENTAL MANUFACTURING I, LLC2958352022-10-16
00302730002485YoungYOUNG DENTAL MANUFACTURING I, LLC2958362022-10-16
00302730002492YoungYOUNG DENTAL MANUFACTURING I, LLC2958612022-10-16
00302730002508ZoobyYOUNG DENTAL MANUFACTURING I, LLC2962012022-10-16
00302730002515ZoobyYOUNG DENTAL MANUFACTURING I, LLC2957122022-10-16
00302730002522ZoobyYOUNG DENTAL MANUFACTURING I, LLC2957132022-10-16
00302730003178D-LISHYOUNG DENTAL MANUFACTURING I, LLC2968762024-07-12
00302730003192D-LISHYOUNG DENTAL MANUFACTURING I, LLC2968782024-07-12
00302730003208D-LISHYOUNG DENTAL MANUFACTURING I, LLC2968792024-07-12
00302730003215D-LISHYOUNG DENTAL MANUFACTURING I, LLC2968942024-07-12
00302730003222D-LISHYOUNG DENTAL MANUFACTURING I, LLC2968932024-07-12
00348783005592Enamel Pro VarnishPREMIER DENTAL PRODUCTS COMPANY90075402024-09-19
00348783005608Enamel Pro VarnishPREMIER DENTAL PRODUCTS COMPANY90075412024-09-19
00348783005615Enamel Pro VarnishPREMIER DENTAL PRODUCTS COMPANY90075422024-09-19
00348783005622Enamel Pro VarnishPREMIER DENTAL PRODUCTS COMPANY90075432024-09-19
00348783005639Enamel Pro VarnishPREMIER DENTAL PRODUCTS COMPANY90075442024-09-19
00348783005646Enamel Pro VarnishPREMIER DENTAL PRODUCTS COMPANY90075452024-09-19
00348783005653Enamel Pro VarnishPREMIER DENTAL PRODUCTS COMPANY90075472024-09-19
00348783005660Enamel Pro VarnishPREMIER DENTAL PRODUCTS COMPANY90075502024-09-19
00353045002349CitrineDHARMA RESEARCH, INC.56-002002016-10-07
00353045002356CitrineDHARMA RESEARCH, INC.56-002022016-10-07
00353045002363CitrineDHARMA RESEARCH, INC.56-002042016-10-07
00723797697115HurriSeal Dentin Desensitizer Snap-N-Go SwabBEUTLICH PHARMACEUTICALS, LLCSnap-N-Go Swab2016-10-01
00810111542500Aqua-Prep FBISCO INC.B-28222022-10-11
00810118107863NuSmile NuNamel VarnishNUSMILE, LTD.NBGNNV502026-01-12
00810118107870NuSmile NuNamel VarnishNUSMILE, LTD.NBNNV502026-01-12
00810118107887NuSmile NuNamel VarnishNUSMILE, LTD.NMNNV502026-01-12
00810118107894NuSmile NuNamel VarnishNUSMILE, LTD.NBGNNV2002026-01-12
00810118107900NuSmile NuNamel VarnishNUSMILE, LTD.NBNNV2002026-01-12
00810118107917NuSmile NuNamel VarnishNUSMILE, LTD.NMNNV2002026-01-12
00850006606474Wonderful DentalRoses and Rubies, LLCFL020121012023-10-27
00850006606634Wonderful DentalRoses and Rubies, LLCFL020421012023-10-27