Registered with FDA
NU Radiance, Inc.
Green Bay, WI, United States. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 15
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name NU Radiance, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | NU Radiance, Inc. | 5 device types | — | Below |
| Canada | Health Canada | Registration holder | NU RADIANCE, INC. | 1 | 2005–2005 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What NU Radiance, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | FloComp-ItNu Radiance Etching GelNu Radiance Liquid Enamel ConditionerPostComp-ItReComp-ItSentry Etching GelSentry Flowable CompositeSentry Posterior CompositeSentry Resin Based Restorative1st Core | 2008 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | Nu Radiance Pit and Fissure Sealant | 2012 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | Nu FormSentry Dental Temp. Crown & Bridge | 2008 |
| Dental CementEMA · Class 2 | Dental cements | Lister | Nu Tempcement | 2008 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Lister | Nu Shield | 2012 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
NU Radiance, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Scientific Pharmaceuticals (6), Sci-Pharm, Inc. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 4 Aug 2004 | K041886 | PROVISO | Scientific Pharmaceuticals | EBG Resin Temporary Crown and Bridge |
| 12 Feb 1999 | K982915 | SCI-PHARM DFV VARNISH | Scientific Pharmaceuticals | LBH Cavity Varnish |
| 2 Dec 1988 | K884081 | INTERIM, TEMPORARY CEMENT | Scientific Pharmaceuticals | EMA Dental Cement |
| 21 Jul 1987 | K872569 | TEMREX ETCHING GEL | Scientific Pharmaceuticals | EBF Resin Tooth Shade Material |
| 21 Feb 1984 | K833810 | CURAY-MATCH PAINT-ON COMPOSITE RESTOR | Scientific Pharmaceuticals | EBF Resin Tooth Shade Material |
| 28 Dec 1982 | K823510 | CURAY ANTERIOR/POSTERIOR RESTORATIVE | Scientific Pharmaceuticals | EBF Resin Tooth Shade Material |
| 24 Nov 1981 | K813091 | FISSURE SEALER & BONDING AGENT | Sci-Pharm, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 17 Mar 1981 | K810479 | SUPPORT | Sci-Pharm, Inc. | EBF Resin Tooth Shade Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NU RADIANCE, INC.FDA reg. 3004967419 | Ashwaubenon, WI, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9069582). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.