FDA.reportPublic FDA data

NuSmile NuNamel Varnish

Primary DI
00810118107917
Brand
NuSmile NuNamel Varnish
Company
NUSMILE, LTD.
Model
NMNNV200
Device description
NuSmile NuNamel Varnish Unit Dose 200 pk - NuMint
Published
2026-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LBHVarnish, Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810118107917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810118107917008101181079178101181079170810118107917

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizing, professionalA 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.

Regulatory Flags#

DUNS number
185497372
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810118108082NuSmile BioCemBCVKXL2026-09-22
08809911118536NuSmile NuCemNCRSKI2026-04-08
08809911118543NuSmile NuCemNCRPKI2026-04-08
08809911118529NuSmile NuCemNUCEMSU2026-07-21
08809911118550NuSmile NuCemNUCEMSUI2026-07-21
00810118108075NuSmile NuCemSNUCEM2026-04-21
08809911118505NuSmile NuCemNCRSK2026-04-14
08809911118512NuSmile NuCemNCRPK2026-04-14
00810118107962NuSmile Bite Stick / Band SeaterBS-0012026-04-08
00810118107979NuSmile Heavy Band PusherBP-0022026-04-08
00810118107986NuSmile 3 Jaw PlierTJP-0032026-04-08
00810118107993NuSmile Bird Beak PlierBBP-0042026-04-08
00810118108006NuSmile Band / Crown Crimping PlierBCP-0052026-04-08
00810118108013NuSmile Heavy Curved ScissorsHCS-0062026-04-08
00810118108020NuSmile Posterior Band RemoverPBR-0072026-04-08
00810118108037NuSmile Tube Crimping PlierTCP-0082026-04-08
00810118108044NuSmile Contouring PlierCP-0092026-04-08
00810118108051NuSmile Hard Wire CutterHWC-0102026-04-08
00810118107948NuSmile NuCemNCRSKI2026-04-08
00810118107955NuSmile NuCemNCRPKI2026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850006606740Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606757Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606788Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606795Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606825Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606832Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606863Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606870Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606900Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606917Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606948Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606955Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606986Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00197998150340Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150371Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150401Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150432Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150463Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150494Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150517Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219092Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219108Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219115Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219139Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219146Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219214Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998486050Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
E22122751VOCO Profluorid Varnish + BioMinVOCO GmbHLBH2026-07-26
00348783015591Bond-PRPREMIER DENTAL PRODUCTS COMPANYLBH2026-06-10
00348783015607Bond-PRPREMIER DENTAL PRODUCTS COMPANYLBH2026-06-10