Talladium Inc
Santa Clarita, CA, US
TALLADIUM, INC. appears in FDA device records in Santa Clarita, CA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Talladium Inc between 1989 and 2016. The busiest year on record is 2015, with 3. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 2010 | 1 |
| 2014 | 1 |
| 2015 | 3 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K152023 | Luminesse Shaded Zirconia SZ | EIH | Substantially Equivalent | |
| K152066 | Luminesse Anterior Zirconia AT | EIH | Substantially Equivalent | |
| K143090 | LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID | EIH | Substantially Equivalent | |
| K142371 | Luminesse PMMA | EBG | Substantially Equivalent | |
| K140848 | LUMINESSE PORCELAIN SYSTEM | EIH | Substantially Equivalent | |
| K100232 | LUMINESSE ZR BLANKS | EIH | Substantially Equivalent | |
| K894085 | TALLADIUM TILITE CERAMIC ALLOY | EJH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2023129 | 2023129 | TALLADIUM, INC. | 27360 WEST MUIRFIELD LN., Santa Clarita, CA 91355 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0512-2021 | Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on the order of a dental professional. | Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bridge restorations has incorrect label. label states Part no. 5336-B1 (98x20mm). However, the item inside the box was Part no. 4302-B1 (95x20mm). An incorrect label may result in compatibility issues when setting up the disc with milling machine fixtures due to size variation. | Class III | Terminated | |
| Z-2943-2020 | Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks. | The linear shrinkage on the zirconia blank disc s part label is incorrect. The average linear shrinkage found on the product label was outside the acceptable range. The acceptable average linear shrinkage ranges between 1.225 to 1.275. The production lot being recalled has a linear shrinkage rate of 2.251 which is above the acceptable range. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain