FDA.reportPublic FDA data

Classic

Primary DI
B77201340
Brand
Classic
Company
NU RADIANCE INC
Model
Patient Kit
Catalog number
0134
Device description
Nu Radiance Classic Teeth Whitening, 10% Carbamide Peroxide, Patient Kit
Published
2021-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B77201340PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Teeth whitening kitA collection of devices intended to whiten natural teeth through bleaching. It typically includes a bleaching agent (e.g., a gel containing a low concentration of an oxidizing agent, such as carbamide peroxide or hydrogen peroxide), a syringe(s), a tray(s), a mouthguard, an applicator (e.g., a brush) and strips to apply/retain the bleaching agent to/on the teeth for a recommended period. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit72 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
148149243
Device count
1
Premarket 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