Not currently registered with FDA under this name
Danville Materials, LLC
San Ramon, CA, United States. Named as applicant on 16 dental 510(k) clearances between 2001 and 2015. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 162001–2015
- Markets registered in
- 7108 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 7 markets
Where regulators' registries name Danville Materials, LLC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Danville Materials, LLC | 16 clearances | 2001–2015 | Below |
| Canada | Health Canada | Registration holder | DANVILLE MATERIALS | 70 | 2003–2023 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Danville Materials | 14 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Danville MaterialsDanville Materials, Inc. · Danville Materials, LLC. · +1 | 12 | 2001–2022 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DANVILLE MATERIALS, INC.DANVILLE MATERIALS · Danville Materials, LLC | 10 | 2005–2020 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DANVILLE MATERIALS INC | 1 | 2010–2010 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | DANVILLE MATERIALS, LLC | 1 | — | 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
510(k) clearances
Clearances on which FDA names Danville Materials, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Nov 2015 | K152349 | Star+ VPS Scannable Impression Material | ELW Impression Material |
| 21 Sep 2015 | K151514 | Prestige | EBF Resin Tooth Shade Material |
| 28 Aug 2015 | K151088 | DMRC Bulk Fill | EBF Resin Tooth Shade Material |
| 18 Mar 2015 | K142886 | DMRC Self-Cure Bracket Adhesive One Step and Primer | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 13 Feb 2015 | K142881 | DMRC Dual Cure Orthodontic Band Cement | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 25 Sep 2012 | K121880 | DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID | EBF Resin Tooth Shade Material |
| 21 Sep 2011 | K111876 | Z BOND, PRELUDE ONE | KLE Resin Tooth Bonding Agent |
| 27 May 2011 | K110642 | SILJETR SYSTEM | EBF Resin Tooth Shade Material |
| 4 Feb 2011 | K102753 | TURBO TEMP 3 | EBG Resin Temporary Crown and Bridge |
| 16 Dec 2009 | K092912 | STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150 | EBF Resin Tooth Shade Material |
| 16 Sep 2009 | K092319 | STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 | ELW Impression Material |
| 31 Mar 2009 | K090106 | PRELUDE ONE | KLE Resin Tooth Bonding Agent |
| 29 Jun 2004 | K040952 | PRELUDE | KLE Resin Tooth Bonding Agent |
| 9 Jan 2004 | K033215 | PREPAIR | KOJ Airbrush |
| 3 May 2002 | K020760 | STARFLOW HV | EBF Resin Tooth Shade Material |
| 10 Oct 2001 | K012354 | SNOWPOST, SNOWLIGHT | ELR Root Canal Post |
Some of these clearances are listed with FDA today by another company: Zest Anchors, LLC (15), Den-Mat Holdings, LLC (1), 3D Dental Designs and Development LLC (1), Young Innovations Inc (1), enCore Laboratory (1), Ortho Dental Lab, LLC (1).
Sources
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 of the most recent filing, which can be a US agent.