NU RADIANCE INC

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

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Filters

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

Varnish, Cavity (LBH) (5)

Premarket Exempt

No Yes

Clear

Nu Shield - B77209740 Catalog Number : 0974

Device Description : Nu Shield 0.4 gram Unit Dose 100 Packet

Device Class : 2

Duns Number: 148149243

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

Nu Shield - B77209760 Catalog Number : 0976

Device Description : Nu Shield 0.4 gram Unit Dose 50 Packet

Device Class : 2

Duns Number: 148149243

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

Nu Shield - B77209900 Catalog Number : 0990

Device Description : Nu Shield 0.25 gram Unit Dose 100 Packet

Device Class : 2

Duns Number: 148149243

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

Nu Shield - B77211000 Catalog Number : 1100

Device Description : Nu Shield 0.4 gram Unit Dose 200 Packet

Device Class : 2

Duns Number: 148149243

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

Nu Shield - B77211170 Catalog Number : 1117

Device Description : Nu Shield 0.25 gram Unit Dose 200 Packet

Device Class : 2

Duns Number: 148149243

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

Classic - B77221070 Catalog Number : 2107

Device Description : Nu Radiance Classic Teeth Whitening, 10% Carbamide Peroxide, 50 Syringe Pack

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Classic - B77221140 Catalog Number : 2114

Device Description : Nu Radiance Classic Teeth Whitening, 16% Carbamide Peroxide, 50 Syringe Pack

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Classic - B77221210 Catalog Number : 2121

Device Description : Nu Radiance Classic Teeth Whitening, 22% Carbamide Peroxide, 50 Syringe Pack

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Classic - B7722138 Catalog Number : 2138

Device Description : Nu Radiance Classic Teeth Whitening, 30% Carbamide Peroxide, 50 Syringe Pack

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

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