Willi Geller Creation and LF Porcelain
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K002904 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 and LF Porcelain is a dental ceramic powder classified as a powder for dental porcelain (Product Code EIH). It is designed for use by dental technicians to fabricate high-aesthetic dental restorations, including porcelain-fused-to-metal crowns, bridges, laminate veneers, and inlays. The material is formulated to provide durability and natural tooth-like appearance in prosthetic applications.
This device is supplied as a powder and is intended for laboratory use only. It is not sterile and is not intended for direct patient application. The product is regulated under FDA 510(k) clearance (K002904) with a decision date of November 6, 2000, under the Dental advisory committee (DE). Storage and handling instructions are not specified in the regulatory data, but proper laboratory conditions should be maintained to preserve integrity.
Frequently asked questions
What types of dental restorations can the Willi Geller Creation and LF Porcelain be used to create, and is it intended for direct patient use?
This dental ceramic powder is specifically formulated for dental technicians to fabricate high-aesthetic restorations like porcelain-fused-to-metal crowns, bridges, laminate veneers, and inlays. It is not sterile and is not intended for direct patient application, meaning it must be processed in a laboratory setting before use in clinical procedures.
How is the Willi Geller Creation and LF Porcelain supplied, and what are its key characteristics?
The product is supplied exclusively as a powder and is designed only for laboratory use by dental technicians. It is formulated to achieve durability and a natural tooth-like appearance in prosthetic applications, but it requires processing (e.g., mixing with liquids) before use.
Is this device single-use or reusable, and what storage considerations should be noted?
Since it is a powder for dental porcelain, it is intended for single-use in fabrication—each batch is meant to be processed into a restoration rather than reused. While specific storage instructions aren’t detailed in regulatory data, it should be kept under proper laboratory conditions to maintain its integrity before use.
What regulatory pathway was followed for FDA clearance, and which advisory committee reviewed it?
The Willi Geller Creation and LF Porcelain received FDA 510(k) clearance (K002904) under the Dental (DE) Advisory Committee, with a decision dated November 6, 2000. The submission was classified as *Substantially Equivalent* (SESE) and followed a traditional review pathway, meaning it was compared to a legally marketed predicate device.
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 AND LF PORCELAIN - Innolitics, Home | Creation Willi Geller, WILLI GELLER CREATION AND LF PORCELAIN 510(k) K002904 - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K002904 | Class II | Active |
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Manufacturer
- Manufacturer
- Jensen Industries, Inc.
Sources (1)
- FDA 510(k) K002904 24 fields · synced Sep 20, 2026