n!ce Glass Ceramic Blocks for Amann Girrbach
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170420 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 Nice Glass Ceramic Blocks for Amann Girrbach are classified as dental ceramic blocks (Product Code: EIH) used in dental laboratories for fabricating restorative and prosthetic dental devices. These blocks are designed to provide a high-strength, aesthetic ceramic material for milling and shaping into crowns, bridges, inlays, onlays, and other dental restorations using computer-aided design and manufacturing (CAD/CAM) systems compatible with Amann Girrbach equipment.
Supplied as non-sterile, single-use blocks, these ceramic materials are intended for use in dental laboratory settings. They are packaged individually and require no special storage conditions beyond protection from physical damage and contamination. The device holds FDA 510(k) clearance under Special Review (K170420) and is compliant with the Medical Device Regulation (MDR) in the European Union, ensuring adherence to stringent safety and performance standards for dental ceramics.
Frequently asked questions
What types of dental restorations can these ceramic blocks be used to fabricate with Amann Girrbach CAD/CAM systems?
The n!ce Glass Ceramic Blocks are designed for milling into a variety of dental restorations, including crowns, bridges, inlays, onlays, and other prosthetic devices. Their high-strength, aesthetic properties make them suitable for computer-aided design and manufacturing (CAD/CAM) workflows compatible with Amann Girrbach equipment, ensuring precise fabrication for laboratory use.
Are these ceramic blocks intended for direct patient use, or are they meant solely for laboratory fabrication?
These blocks are non-sterile and single-use, intended exclusively for dental laboratory settings. They are milled and shaped into restorations before being used in clinical applications by dentists. The blocks themselves are not sterilized or meant for direct patient contact.
Do these blocks require special storage conditions, or can they be kept in standard laboratory environments?
No special storage conditions are required beyond protecting the blocks from physical damage and contamination. They are packaged individually and can be stored in a typical dental laboratory setting, as long as they remain undamaged and uncontaminated until use.
What regulatory pathways have these ceramic blocks followed for market authorization?
The n!ce Glass Ceramic Blocks hold FDA 510(k) clearance under Special Review (K170420) and comply with the EU Medical Device Regulation (MDR). The FDA classified them as substantially equivalent to a predicate device under Product Code EIH (Dental Ceramics), while the MDR ensures they meet stringent EU safety and performance standards for dental ceramics.
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 | K170420 | Class II | Active |
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Manufacturer
- Manufacturer
- Institut Straumann AG
Sources (2)
- FDA 510(k) K170420 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026