Data / Medical devices / United States / Nu Radiance, Inc.
Nu Radiance, Inc.: FDA-registered device maker in Ashwaubenon, WI, United States, 8 510(k) clearances
Nu Radiance, Inc. is registered with the FDA (registration 3004967419) in Ashwaubenon, WI, United States. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 4, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004967419
- Address
- 795 Coronis Way, Ashwaubenon, WI, United States, 54304
- Owner or operator
- NU RADIANCE, INC. (9069582)
- Roles
- Repackager or relabeler
- First device listed
- December 1, 2008
- Registered through
- 2026
- Brand names listed
- 1st Core, FloComp-It, Nu Form, Nu Radiance Etching Gel, Nu Radiance Liquid Enamel Conditioner, Nu Radiance Pit and Fissure Sealant, Nu Shield, Nu Tempcement and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Dental | EMA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 4, 2004 | K041886 | PROVISO | EBG | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| February 12, 1999 | K982915 | SCI-PHARM DFV VARNISH | LBH | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| December 2, 1988 | K884081 | INTERIM, TEMPORARY CEMENT | EMA | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| July 21, 1987 | K872569 | TEMREX ETCHING GEL | EBF | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| February 21, 1984 | K833810 | CURAY-MATCH PAINT-ON COMPOSITE RESTOR | EBF | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| December 28, 1982 | K823510 | CURAY ANTERIOR/POSTERIOR RESTORATIVE | EBF | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| November 24, 1981 | K813091 | FISSURE SEALER & BONDING AGENT | EBC | Substantially Equivalent | Sci-Pharm, Inc. | accessdata.fda.gov |
| March 17, 1981 | K810479 | SUPPORT | EBF | Substantially Equivalent | Sci-Pharm, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Material, Tooth Shade, Resin
- All makers of Sealant, Pit And Fissure, And Conditioner
- All makers of Varnish, Cavity
- All makers of Cement, Dental
Updated August 4, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.