FDA Registration
Active
🇺🇸 United States
NU RADIANCE, INC.
Reg #: 3004967419
·
FEI: 3004967419
·
Expires 2026
Products
5
Proprietary Names
15
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- NU RADIANCE, INC.
- Registration Number
- 3004967419
- FEI Number
- 3004967419
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 795 CORONIS WAY
- City
- Ashwaubenon
- State
- WI
- ZIP
- 54304
- Country
- US
Regulatory Submissions
- 510(k) Number
- K982915
Owner / Operator
- Firm Name
- NU RADIANCE, INC.
- Operator Number
- 9069582
- Address
- 795 CORONIS WAY, --*
- City
- Green Bay
- State
- WI
- Postal Code
- 54304
- Country
- US
- Correspondent
- TOM - NOVAK
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2012-03-06 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2012-03-06 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2008-12-01 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2012-03-06 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2008-12-01 |
Proprietary Names
Nu Shield
Nu Radiance Liquid Enamel Conditioner
Nu Radiance Etching Gel
Sentry Etching Gel
1st Core
Nu Tempcement
PostComp-It
Sentry Posterior Composite
ReComp-It
Sentry Resin Based Restorative
Nu Radiance Pit and Fissure Sealant
Sentry Dental Temp. Crown & Bridge
Nu Form
Sentry Flowable Composite
FloComp-It
Establishment Types
Repack or Relabel Medical Device