Ice Zirkon Transluzent
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132230 FDA 510(k)
- FDA Product Code
- EIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.6660 FDA 510(k)
- Regulation Number
- 872.6660 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ice Zircon Transluzent is a dental material classified as a ceramic dental core build-up material (Product Code: EIH). It is designed for use in dental restorations, providing structural support and translucency to match natural tooth aesthetics during the fabrication of zirconia-based crowns and bridges.
This material is supplied as a powder for mixing with a liquid activator to form a paste, intended for single-use applications in dental laboratories. It is intended for use in non-invasive settings such as dental labs and is regulated under FDA 510K clearance (K132230) and MDR compliance. The translucent properties enhance optical integration with zirconia frameworks, ensuring clinical accuracy in prosthetic dentistry.
Frequently asked questions
What is the Ice Zircon Transluzent used for in dental restorations?
The Ice Zircon Transluzent is a ceramic dental core build-up material specifically designed to provide structural support during the fabrication of zirconia-based crowns and bridges. Its translucent properties help match the natural aesthetics of teeth, ensuring better optical integration with zirconia frameworks for more lifelike restorations.
How is the Ice Zircon Transluzent supplied and intended for use?
It is supplied as a powder that must be mixed with a liquid activator to form a paste. This material is intended for single-use applications in dental laboratories, where it is used to build up the core structure of zirconia restorations before final fabrication.
Is this product reusable, or is it meant for one-time use?
The Ice Zircon Transluzent is explicitly intended for single-use applications. Once mixed into a paste, it is designed to be used once in dental laboratory procedures, ensuring sterility and consistency for each restoration.
What regulatory pathways does the Ice Zircon Transluzent follow?
The product is regulated under FDA 510K clearance (K132230) with a decision classification of *Substantially Equivalent* and reviewed by the Dental (DE) Advisory Committee. It also complies with MDR (Medical Device Regulation) standards, confirming its adherence to both U.S. and European Union regulatory requirements.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K132230 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zirkonzahn Srl
Sources (2)
- FDA 510(k) K132230 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026