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Willi Geller Creation CP Porcelain

FDA 510(k)

Class II (US FDA 510(k))

510(k) K043221

by Jensen Industries, Inc.

Identifiers

510(k) Number
K043221 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)

Willi Geller Creation CP Porcelain is a pressable dental ceramic material classified as a dental ceramic for crowns, bridges, inlays, and veneers (Product Code: EIH). It is designed for fabricating substructures and full-contour restorations in dental prosthetics, including porcelain-fused-to-metal restorations and laminate veneers. The material is engineered to meet the thermal expansion requirements of metal frameworks, ensuring compatibility with both precious and non-precious alloys.

This ceramic is supplied as a dental laboratory material for use by trained dental technicians. It is intended for single-use in fabrication, requiring sterilization of tools and indirect handling to maintain integrity. The product holds an FDA 510(k) clearance (K043221) under the Traditional review pathway, affirming its substantial equivalence to a predicate device. Storage and handling must adhere to manufacturer guidelines to preserve material properties for clinical applications.

Frequently asked questions

What types of dental restorations can the Willi Geller Creation CP Porcelain be used to fabricate, and how does it ensure compatibility with metal frameworks?

The Willi Geller Creation CP Porcelain is specifically designed for fabricating substructures and full-contour restorations, including crowns, bridges, inlays, veneers, and porcelain-fused-to-metal restorations. Its thermal expansion properties are engineered to match those of both precious and non-precious metal alloys, ensuring compatibility and preventing issues like cracking or detachment during clinical use.

Is this ceramic material intended for direct patient application, or is it meant for use by dental technicians in a laboratory setting?

This material is exclusively intended for use by trained dental technicians in a laboratory setting. It is not meant for direct patient application but rather for fabricating restorations that will later be fitted to patients. The product is supplied as a laboratory material, requiring indirect handling to maintain its integrity.

How should the Willi Geller Creation CP Porcelain be stored, and what precautions should be taken to preserve its properties?

Storage and handling must strictly follow the manufacturer’s guidelines to maintain the material’s properties. While specific instructions are not detailed here, proper storage conditions—such as avoiding moisture, extreme temperatures, or contamination—are critical to preserving the ceramic’s performance for clinical applications. Always refer to Jensen Industries’ documentation for precise storage recommendations.

Is the Willi Geller Creation CP Porcelain intended for single-use or can it be reused after fabrication?

The material is designed for single-use in fabrication, meaning each batch is intended to be used once for creating a restoration. Since it is a ceramic, reuse is not practical or recommended. Instead, tools and equipment used in the fabrication process must be properly sterilized to ensure patient safety and maintain the material’s integrity.

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: WILLI GELLER CREATION PORCELAIN by JENSEN INDUSTRIES, INC. | FDA 510 (k ..., WILLI GELLER CREATION CP PORCELAIN (K043221) — FDA 510 (k) | Innolitics, Home | Creation Willi Geller, Creation CC | Creation Willi Geller

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Jensen Industries, Inc.

Sources (1)

  • FDA 510(k) K043221 24 fields · synced Sep 19, 2026