Prettau ICE Z-White Zirconia Blanks
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183304 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 Prettau ICE Z-White Zirconia Blanks are dental zirconia blanks designed for computer-aided manufacturing (CAM) and milling in restorative dentistry. These blanks are used as a substrate for fabricating high-strength, esthetic dental restorations, including crowns, bridges, inlays, and onlays, through CAD/CAM technology.
Supplied as single-use, non-sterile items, these blanks are intended for use in dental laboratories and clinics equipped with CAD/CAM milling systems. They are regulated under the FDA’s 510(k) clearance process (K183304) and comply with the EU Medical Device Regulation (MDR). The product code EIH categorizes them within dental advisory committees, and they are manufactured by Zirkonzahn Srl in Gais, Italy.
Frequently asked questions
Are these zirconia blanks meant for direct patient placement, or do they require additional processing before use in the mouth?
These Prettau ICE Z-White zirconia blanks are designed for computer-aided manufacturing (CAM) milling in dental labs or clinics. They serve as a substrate for fabricating restorations like crowns, bridges, inlays, and onlays, which must be further processed (e.g., sintered, glazed, or veneered) before clinical use. The blanks themselves are not ready for direct placement in the patient.
How are these zirconia blanks supplied, and do they require sterilization before use?
The Prettau ICE Z-White zirconia blanks are supplied as single-use, non-sterile items. Since they are intended for milling in a controlled laboratory or clinical environment, sterilization is not required before processing. Sterilization would occur only after milling and final restoration fabrication, following standard dental protocols.
What regulatory pathways have been followed for these zirconia blanks, and how does that affect their use in the U.S. and EU?
These blanks are regulated under the FDA’s 510(k) clearance process (K183304) and comply with the EU Medical Device Regulation (MDR). In the U.S., they are classified as substantially equivalent to a predicate device, allowing commercial distribution after FDA clearance. In the EU, MDR compliance ensures they meet safety, performance, and regulatory requirements for dental use within the European market.
Are there different sizes or models available for these zirconia blanks, and how might a clinician or lab choose the right one?
While the provided data does not specify exact sizes or models, the Prettau ICE Z-White blanks are designed for CAD/CAM milling, implying they come in standardized dimensions to accommodate various dental restoration shapes (e.g., crowns, bridges). Clinicians or labs would select the appropriate blank based on the restoration type, patient anatomy, and milling system compatibility, typically consulting the manufacturer’s sizing guides or technical documentation for precise fit.
How should these zirconia blanks be stored to maintain their integrity before use?
Since these are non-sterile, single-use items, they should be stored in a clean, dry environment protected from moisture, dust, and physical damage. The manufacturer’s packaging (if sealed) should remain intact until use to prevent contamination. Proper storage ensures the blanks retain their structural integrity for milling, though they do not require refrigeration or specialized conditions beyond standard lab/clinic storage practices.
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 | K183304 | Class II | Active |
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Manufacturer
- Manufacturer
- Zirkonzahn Srl
Sources (2)
- FDA 510(k) K183304 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026