FDA.reportPublic FDA data

Nu Shield

Primary DI
B77209740
Brand
Nu Shield
Company
NU RADIANCE INC
Model
0.4 gram - 100 pack
Catalog number
0974
Device description
Nu Shield 0.4 gram Unit Dose 100 Packet
Published
2019-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
B77209740PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizingA substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and 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., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8668993207info@nuradiance.com

Regulatory Flags#

DUNS number
148149243
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815143001902Sentry Dental TC&BShade Bleach16-10012023-06-12
00815143001919Sentry Dental TC&BShade A116-10022023-06-12
00815143001926Sentry Dental TC&BShade A216-10032023-06-12
00815143001933Sentry Dental TC&BShade A316-10042023-06-12
00815143001940Sentry Dental TC&BShade C216-10052023-06-12
00851309000006NovaExtra SmallGL10XS2022-07-19
00851309000075NovaSmallGL10S2022-07-19
00851309000082NovaMediumGL10M2022-07-19
00851309000099NovaLargeGL10L2022-07-19
00851309000105NovaExtra LargeGL10XL2022-07-19
00851309000167Super Flex Nitrile Exam GlovesExtra SmallGL90XS2022-07-19
00851309000181Super Flex Nitrile Exam GlovesSmallGL90S2022-07-19
00851309000204Super Flex Nitrile Exam GlovesMediumGL90M2022-07-19
00851309000280Super Flex Nitrile Exam GlovesLargeGL90L2022-07-19
00851309000365Super Flex Nitrile Exam GlovesExtra LargeGL90XL2022-07-19
00851309000433Blue Silk Nitrile Exam GlovesExtra SmallGL96XS2022-07-19
00851309000464Blue Silk Nitrile Exam GlovesSmallGL96S2022-07-19
00851309000471Blue Silk Nitrile Exam GlovesmediumGL96m2022-07-19
00851309000488Blue Silk Nitrile Exam GloveslargeGL96L2022-07-19
00851309000495Blue Silk Nitrile Exam Glovesextra largeGL96XL2022-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20827854027120Tom's of Maine Sensitive + Rapid Relief Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
20827854027571Tom's of Maine Sensitive + Whitening Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
506058610873033M™ Clinpro™3M COMPANYLBH2025-10-15
10818207025064ReminGelVista DentalLBH2025-10-09
07615208299373Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-07-10
07615208292893Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-03-20
00302730003178D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003192D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003208D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003215D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003222D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
07615208474459Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2024-04-05
07615208474091Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2024-03-25
106058610839633M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839703M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839873M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839943M™ Clinpro™3M COMPANYLBH2023-12-14
106058610840073M™ Clinpro™3M COMPANYLBH2023-12-14
106058610840143M™ Clinpro™3M COMPANYLBH2023-12-14
106058610840213M™ Clinpro™3M COMPANYLBH2023-12-14
10810111542873FluoroCalBISCO INC.LBH2023-12-11
10810111542897FluoroCalBISCO INC.LBH2023-12-11
10371347011590Advance Dental ProductsThe Atlanta Dental Supply CompanyLBH2023-11-29
10732224005550Sparkle V Sodium Fluoride Varnish, CherryCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224005567Sparkle V Sodium Fluoride Varnish, CaramelCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224005574Sparkle V Sodium Fluoride Varnish, MelonCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224000302Crosstex InternationalCROSSTEX INTERNATIONAL, INC.LBH2023-06-20
10732224000319Crosstex InternationalCROSSTEX INTERNATIONAL, INC.LBH2023-06-20
20035000992974Toms Sensitive + Whitening Fluoride-Free Toothpaste TOM'S OF MAINE, INC.LBH2023-06-02
20810063753928Safco CleanCare Essential Prophy PasteSAFCO DENTAL SUPPLY CO.LBH2022-12-02