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

Cement, Dental (EMA) (2) Varnish, Cavity (LBH) (2) Crown And Bridge, Temporary, Resin (EBG) (1)

Premarket Exempt

No Yes

Clear

Nu TempCement NE - B77207780 Catalog Number : 0778

Device Description : Nu TempCement NE - One Syringe Kit

Device Class : 2

Duns Number: 148149243

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Nu TempCement NE - B77207850 Catalog Number : 0785

Device Description : Nu TempCement NE - Two Syringe Kit

Device Class : 2

Duns Number: 148149243

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Nu Form - B77208080 Catalog Number : 0808

Device Description : Nu Form TC&B Shade Bleach

Device Class : 2

Duns Number: 148149243

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Forte - B77208130 Catalog Number : 0813

Device Description : Nu Radiance Forte Teeth Whitening, Maintenance Kit

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Forte - B77208150 Catalog Number : 0815

Device Description : Nu Radiance Forte Teeth Whitening, Touch Up Kit

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Forte - B77208200 Catalog Number : 0820

Device Description : Nu Radiance Forte Teeth Whitening, Patient Kit

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Forte - B77208530 Catalog Number : 0853

Device Description : Nu Radiance Forte Teeth Whitening, 36 Syringe Bulk Pack

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Nu Seal - B77209070 Catalog Number : 0907

Device Description : Nu Seal - 1 Syringe Kit

Device Class : 2

Duns Number: 148149243

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

Nu Seal - B77209140 Catalog Number : 0914

Device Description : Nu Seal - 4 Syringe Kit

Device Class : 2

Duns Number: 148149243

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

Eure-Ca - B77209290 Catalog Number : 0929

Device Description : Nu Radiance Eure-Ca, Ten Syringe Pack

Device Class :

Duns Number: 148149243

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

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