Manufacturer registered with FDA
Talladium, Inc.
Valencia, CA, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 7 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 20
- 510(k) clearances
- 71989–2016
- Markets registered in
- 554 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1980–2026
Registered in 5 markets
Where regulators' registries name Talladium, 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 | Manufacturer | Talladium, Inc. | 7 clearances | 1989–2016 | Below |
| South Korea | MFDS | Manufacturer | Talladium Inc.Talladium,Inc. · Talladium INC. · +2 | 44 | 1999–2013 | Pure Global AI |
| Canada | Health Canada | Registration holder | TALLADIUM, INC. | 5 | 2006–2015 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | TALLADIUM INCORPORATEDTalladium, Inc. | 4 | 2009–2017 | Pure Global AI |
| Australia | TGA | Manufacturer | Talladium Inc | 1 | 2020–2020 | 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 Talladium, 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Luminesse Anterior Zirconia ATLuminesse Multilayer Anterior Zirconia ATLuminesse One For All ZRLuminesse One for All ZR MLLuminesse Porcelain SystemLuminesse Pre-Sintered Zirconia Coloring LiquidLuminesse Shaded Anterior Zirconia ATLuminesse Shaded Zirconia SZLuminesse ZR Blanks | 2013 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | Hi-Tech Pre-SolderLaser Welding wireLuminesse Chrome-Cobalt DiscsLuminesse Titanium DiscsPost SolderTALLADIUM TILITE CERAMIC ALLOYTalladium Tilite Ceramic Alloy (Unfortunates)Tilite-Chrome | 2007 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Luminesse AcetalLuminesse PMMALuminesse Temporaries | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Talladium, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 15 Sep 2016 | K152023 | Luminesse Shaded Zirconia SZ | EIH Porcelain Powder |
| 21 Oct 2015 | K152066 | Luminesse Anterior Zirconia AT | EIH Porcelain Powder |
| 15 Jun 2015 | K143090 | LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID | EIH Porcelain Powder |
| 24 Apr 2015 | K142371 | Luminesse PMMA | EBG Resin Temporary Crown and Bridge |
| 17 Dec 2014 | K140848 | LUMINESSE PORCELAIN SYSTEM | EIH Porcelain Powder |
| 21 May 2010 | K100232 | LUMINESSE ZR BLANKS | EIH Porcelain Powder |
| 20 Dec 1989 | K894085 | TALLADIUM TILITE CERAMIC ALLOY | EJH Base Metal Alloy |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TALLADIUM, INC.FDA reg. 2023129 | Santa Clarita, CA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2023129). 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.