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Sign in to claim this brandDISTRIBUDENT, LLC
US
Last updated May 23, 2026
What DISTRIBUDENT, LLC makes
Distribudent, LLC manufactures dental appliance fabrication materials, specifically ceramic-based products designed for dental restorations and prosthetics. Their portfolio includes materials used in the creation of crowns, bridges, and other fixed dental prostheses, focusing on high-strength, biocompatible ceramics.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Distribudent, LLC operates from the United States, adhering to applicable U.S. regulatory requirements for dental materials.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Distribudent, LLC manufacture?
Distribudent, LLC specializes in dental appliance fabrication materials, specifically ceramic-based products. These materials are primarily used for dental restorations and prosthetics, such as crowns, bridges, and other fixed dental prostheses. The focus is on high-strength, biocompatible ceramics that meet the demands of dental applications.
Where is Distribudent, LLC based, and what regulatory framework does it follow?
Distribudent, LLC is based in the United States. Since its devices fall under U.S. jurisdiction, they must comply with applicable FDA regulations for medical devices. The company’s products are designed and manufactured in accordance with these regulatory requirements to ensure safety, performance, and quality.
How are Distribudent, LLC’s devices classified under FDA regulations?
Distribudent, LLC’s dental appliance fabrication materials are classified as Class II medical devices by the FDA. This classification is determined based on the risk associated with the device’s use, where Class II devices require special controls in addition to general controls to ensure their safety and effectiveness. The classification reflects the need for validated performance standards and post-market surveillance for these ceramic materials.
Are Distribudent, LLC’s devices listed in any regulatory databases?
Yes, Distribudent, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability. Listing in this database is a requirement for Class II devices in the U.S., supporting regulatory oversight and patient safety.
What is the primary purpose of the ceramic materials manufactured by Distribudent, LLC?
The ceramic materials produced by Distribudent, LLC are specifically engineered for dental appliance fabrication, particularly for creating durable, natural-looking restorations such as crowns, bridges, and inlays. These materials are chosen for their high strength, biocompatibility, and aesthetic properties, which are critical in dental prosthetics to ensure long-term functionality and patient comfort.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 080458846
Catalogue (136)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ZIRento | Z16D3-2598ST | FDA UDI | Class II | Active |
| ZIRento | Z16C3-2098ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16B1-1598ST | FDA UDI | Class II | Active |
| ZIRento | Z16A4-2598ST | FDA UDI | Class II | Active |
| ZIRento | Z16C4-2098ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16C4-2598ST | FDA UDI | Class II | Active |
| ZIRento | Z16A4-1598ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16D3-1598ST-SI | FDA UDI | Class II | Active |
| ZIRento | ZW-2098ST | FDA UDI | Class II | Active |
| ZIRento | Z16C2-1298ST | FDA UDI | Class II | Active |
| ZIRento | ZW-2598ST | FDA UDI | Class II | Active |
| ZIRento | Z16A35-1598ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16C2-1598ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16B4-2098ST | FDA UDI | Class II | Active |
| ZIRento | Z16A4-2598ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16D4-1598ST | FDA UDI | Class II | Active |
| ZIRento | Z16D2-1598ST | FDA UDI | Class II | Active |
| ZIRento | Z16B2-2598ST | FDA UDI | Class II | Active |
| ZIRento | Z16C3-1298ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16B2-1598ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16D2-1298ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16D4-1298ST | FDA UDI | Class II | Active |
| ZIRento | Z16A4-1298ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16C3-1298ST | FDA UDI | Class II | Active |
| ZIRento | Z16B2-1298ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16C1-2598ST | FDA UDI | Class II | Active |
| ZIRento | Z16A3-2598ST | FDA UDI | Class II | Active |
| ZIRento | Z16A1-2598ST | FDA UDI | Class II | Active |
| ZIRento | Z16C2-1598ST | FDA UDI | Class II | Active |
| ZIRento | Z16C1-1598ST | FDA UDI | Class II | Active |
| ZIRento | Z16A3-2098ST | FDA UDI | Class II | Active |
| ZIRento | Z16B1-1598ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16B4-2598ST | FDA UDI | Class II | Active |
| ZIRento | Z16D4-2598ST | FDA UDI | Class II | Active |
| ZIRento | Z16C2-2598ST | FDA UDI | Class II | Active |
| ZIRento | Z16B3-1298ST | FDA UDI | Class II | Active |
| ZIRento | Z16C2-2598ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16B1-1298ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16D4-1598ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16A35-2598ST | FDA UDI | Class II | Active |
| ZIRento | Z16A2-2598ST | FDA UDI | Class II | Active |
| ZIRento | Z16C1-2598ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16D2-1298ST | FDA UDI | Class II | Active |
| ZIRento | Z16D4-2098ST-SI | FDA UDI | Class II | Active |
| ZIRento | ZW-1298ST | FDA UDI | Class II | Active |
| ZIRento | Z16D4-2098ST | FDA UDI | Class II | Active |
| ZIRento | Z16D4-2598ST-SI | FDA UDI | Class II | Active |
| ZIRento | Z16D2-2098ST | FDA UDI | Class II | Active |
| ZIRento | Z16C3-2098ST | FDA UDI | Class II | Active |
| ZIRento | Z16A2-2598ST-SI | FDA UDI | Class II | Active |
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