priti multidisc ZrO2 High Translucent
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161025 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)
priti multidisc ZrO2 High Translucent is a dental zirconia material that combines the properties of 4Y-TZP and 5Y-TZP. It provides high strength throughout the restoration with a smooth transition between layers, resulting in a gradual progression of strength. This material is suitable for a wide range of dental indications.
The device is supplied as round blanks with a diameter of 98.5 mm and is intended for use with milling machines. It is designed for restorations with up to three pontics and offers high aesthetics. The device has received FDA 510(k) clearance with the product code EIH.
Frequently asked questions
What is the priti multidisc ZrO2 High Translucent used for?
This dental zirconia material is suitable for a wide range of dental indications, providing high strength throughout restorations with a smooth transition between layers. It's designed for restorations with up to three pontics and offers high aesthetics.
How is the priti multidisc ZrO2 High Translucent supplied?
The device is supplied as round blanks with a diameter of 98.5 mm and is specifically intended for use with milling machines. This format allows for precise customization according to specific dental restoration requirements.
What are the key properties of this zirconia material?
The priti multidisc ZrO2 High Translucent combines the properties of both 4Y-TZP and 5Y-TZP zirconia types. This combination provides high strength throughout the restoration with a smooth transition between layers, resulting in a gradual progression of strength that enhances durability.
What regulatory clearance has this device received?
The priti multidisc ZrO2 High Translucent has received FDA 510(k) clearance with the product code EIH. It was determined to be substantially equivalent to predicate devices through the traditional clearance process.
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. Sources consulted: priti®multidisc ZrO2 High Translucent | pritidenta, priti®multidisc ZrO2 Multi Translucent PLUS | pritidenta, ZrO2 dental material - priti®multidisc - pritidenta GmbH - milling ..., priti®multidisc ZrO2, High Translucent / pritidenta GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161025 | Class II | Active |
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Manufacturer
- Manufacturer
- Pritidenta GmbH
Sources (1)
- FDA 510(k) K161025 24 fields · synced Sep 25, 2026