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TALLADIUM, INC.

US

Last updated September 17, 2026

What TALLADIUM, INC. makes

Talladium, Inc. produces dental materials for appliance fabrication, including ceramic-based zirconia blocks and polymer-based PMMA discs for dental prosthetics. Their portfolio includes dental casting alloys—both noble and non-noble—along with specialized powders, modifiers, and dyes for dentin, incisal layers, and multilayer anterior restorations. The company also supplies materials for soldering and pre-shaded dental models to enhance aesthetic outcomes in restorative dentistry.

All listed devices fall under Class II regulatory classification in the U.S. and are recorded in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. medical device regulations.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
27360 WEST MUIRFIELD LN., Santa Clarita, CA, 91355
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
2023129
DUNS Number
094430642

Catalogue (1101)

Page 7 of 23
DeviceModel / ReferenceRegistriesClassStatus
Luminesse Zirconia Blocks 5118
FDA UDI
Class IIActive
Luminesse Zirconia Discs 5142NR
FDA UDI
Class IIActive
Luminesse Multi-Layer PMMA Discs 5320A0
FDA UDI
Class IIActive
Luminesse HF Dentin Modifiers 1958Y
FDA UDI
Class IIActive
Luminesse Low Fusing Dentin Powder 1902A35
FDA UDI
Class IIActive
Tilite Luminite Alloy - Luminite Press 1915
FDA UDI
Class IIActive
Luminesse Zirconia Blocks 5169
FDA UDI
Class IIActive
Luminesse Zirconia Blocks 5139
FDA UDI
Class IIActive
Luminesse Zirconia Discs 5081MLB1HT
FDA UDI
Class IIActive
Luminesse Clear PMMA Discs 5222Z
FDA UDI
Class IIActive
Luminesse Zirconia Discs 5147ATV2
FDA UDI
Class IIActive
Tilite Chrome Discs 25227
FDA UDI
Class IIActive
Luminesse Zirconia Discs 19816-OFAML-C3
FDA UDI
Class IIActive
Luminesse HF Margin 1959M2
FDA UDI
Class IIActive
Luminesse Multi-Layer PMMA Discs 4303A4
FDA UDI
Class IIActive
Luminesse ZR Incisal Translucents 1977B
FDA UDI
Class IIActive
Luminesse Ti-Cam Discs 5230
FDA UDI
Class IIActive
Luminesse Universal Stain Shades 1906W
FDA UDI
Class IIActive
Luminesse Multi-Layer PMMA Discs 5320B4
FDA UDI
Class IIActive
Luminesse Multi-Layer PMMA Discs 4301A35
FDA UDI
Class IIActive
Luminesse Zirconia Discs 5147NR
FDA UDI
Class IIActive
Luminesse Ti-Cam Discs 5271
FDA UDI
Class IIActive
Luminesse Low Fusing Dentin Powder 1902C2
FDA UDI
Class IIActive
Luminesse Shaded PMMA Discs 5307B2
FDA UDI
Class IIActive
Luminesse Chrome Cobalt Discs 5241
FDA UDI
Class IIActive
Luminesse Chrome Cobalt Discs 5248
FDA UDI
Class IIActive
Luminesse Shaded PMMA Discs 5308C4
FDA UDI
Class IIActive
Luminesse Low Fusing Dentin Powder 1902B1
FDA UDI
Class IIActive
Luminesse Zirconia Discs 5165T
FDA UDI
Class IIActive
Luminesse Zirconia Blocks 5093
FDA UDI
Class IIActive
Luminesse Shaded PMMA Discs 5308D1
FDA UDI
Class IIActive
Luminesse Zirconia Blocks 5138B1
FDA UDI
Class IIActive
Luminesse Zirconia Discs 5136T
FDA UDI
Class IIActive
Luminesse Zirconia Discs 19514-OFA
FDA UDI
Class IIActive
Luminesse Shaded PMMA Discs 5308C2
FDA UDI
Class IIActive
Luminesse Multi-Layer PMMA Discs 5396D2
FDA UDI
Class IIActive
Tilite Chrome Discs 25223
FDA UDI
Class IIActive
Luminesse Zirconia Discs 5144A3
FDA UDI
Class IIActive
Luminesse Zirconia Discs 5182AT
FDA UDI
Class IIActive
OFA Coloring Liquid CL-OFA-KIT
FDA UDI
Class IIActive
Luminesse Zirconia Blocks 5148
FDA UDI
Class IIActive
Luminesse Zirconia Discs 5147B3
FDA UDI
Class IIActive
Luminesse Clear PMMA Discs 5215
FDA UDI
Class IIActive
Luminesse Zirconia Blocks 5146
FDA UDI
Class IIActive
Luminesse Zirconia Blocks 5133C2
FDA UDI
Class IIActive
Luminesse Zirconia Discs 5126
FDA UDI
Class IIActive
Luminesse Multi-Layer PMMA Discs 4303C4
FDA UDI
Class IIActive
Luminesse HF Dentin Powder 1952A35
FDA UDI
Class IIActive
Luminesse Zirconia Blocks 5090HS
FDA UDI
Class IIActive
Luminesse Ti-Cam Discs 5257
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Talladium, Inc. has two recall records, both initiated in 2020—one on August 6 and the other on October 9—with both currently marked as terminated. The recalls involved labeling inaccuracies: one concerned incorrect linear shrinkage values on zirconia blank discs, where the stated shrinkage rate fell outside the acceptable range of 1.225 to 1.275, and the other involved mislabeled heat-cured polymethylmethacrylate (PMMA) milling blanks, where the product inside did not match the label’s specified part number.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Oct 9, 2020Z-0512-2021—terminated

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.

Aug 6, 2020Z-2943-2020—terminated

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.