Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004967419

FEI Number

3004967419

Entity Name

NU RADIANCE, INC.

City/State/Country

Ashwaubenon, WI, US

Establishment Address

795 CORONIS WAY, Ashwaubenon, WI 54304, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

NU RADIANCE, INC. (Owner Number: 9069582)

Owner / Operator Contact Address

795 CORONIS WAY, --*, Green Bay, WI 54304, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K823510

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2012-03-06
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-03-06
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-12-01
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-12-01
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-03-06

Official Correspondent

TOM NOVAK

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NU RADIANCE, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033295	Novamin Technology, Inc.	BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN	2003-10-28
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004967419. Last updated year: 2026. Please use registration number 3004967419 when referencing this establishment in official correspondence.