NU RADIANCE INC

Address:795 CORONIS WAY,Ashwaubenon,WI,54304,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Premarket Exempt

No Yes

Clear

Classic - B77201500 Catalog Number : 0150

Device Description : Nu Radiance Classic Teeth Whitening, 10% Carbamide Peroxide, 36 Syringe Bulk Pack

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Classic - B77202260 Catalog Number : 0226

Device Description : Nu Radiance Classic Teeth Whitening, 16% Carbamide Peroxide, Maintenance Kit

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Classic - B77202330 Catalog Number : 0233

Device Description : Nu Radiance Classic Teeth Whitening, 16% Carbamide Peroxide, Patient Kit

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Classic - B77202420 Catalog Number : 0242

Device Description : Nu Radiance Classic Teeth Whitening, 16% Carbamide Peroxide, Ten Syringe Pack

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Classic - B77202590 Catalog Number : 0259

Device Description : Nu Radiance Classic Teeth Whitening, 16% Carbamide Peroxide, 36 Syringe Bulk Pack

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Classic - B77203250 Catalog Number : 0325

Device Description : Nu Radiance Classic Teeth Whitening, 22% Carbamide Peroxide, Maintenance Kit

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Classic - B77203320 Catalog Number : 0332

Device Description : Nu Radiance Classic Teeth Whitening, 22% Carbamide Peroxide, Patient Kit

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Classic - B77203410 Catalog Number : 0341

Device Description : Nu Radiance Classic Teeth Whitening, 22% Carbamide Peroxide, Ten Syringe Pack

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Classic - B77203580 Catalog Number : 0356

Device Description : Nu Radiance Classic Teeth Whitening, 22% Carbamide Peroxide, 36 Syringe Bulk Pack

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Classic - B77203650 Catalog Number : 0365

Device Description : Nu Radiance Classic Teeth Whitening, 30% Carbamide Peroxide, Maintenance Kit

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

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