Identifiers
- 510(k) Number
- K241089 FDA 510(k)
- FDA Product Code
- EBI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3760 FDA 510(k)
- Regulation Number
- 872.3760 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The KeyPrint KeyDenture Base is a dental device classified as a Denture Base (Product Code: EBI), designed for use in the fabrication of removable dentures. It serves as the foundational structure upon which denture teeth are mounted, providing mechanical support and stability for prosthetic restorations. Manufactured for digital denture fabrication, this base is engineered to ensure compatibility with 3D printing workflows, enabling precise and efficient production. Its composition and design aim to replicate natural gum tissue aesthetics while maintaining durability for patient use.
The KeyDenture Base is supplied as a reusable material in 1 kg packs (Reference Code: 4220430) and is intended for use in dental laboratories. It is not sterile at time of supply and must be processed according to standard dental laboratory protocols before use. The device is FDA-cleared under a Traditional 510(k) pathway (K241089) as substantially equivalent to predicate devices, adhering to dental regulatory standards. Storage should follow manufacturer guidelines to preserve material integrity, and compatibility with MRI environments is not specified.
Frequently asked questions
What is the KeyPrint KeyDenture Base used for in a dental lab setting?
The KeyPrint KeyDenture Base is specifically designed as a foundational structure for fabricating removable dentures. It serves as the base upon which denture teeth are mounted, providing mechanical support and stability for the final prosthetic restoration. Its digital compatibility makes it ideal for integration into 3D printing workflows, allowing for precise and efficient denture fabrication.
Is the KeyDenture Base intended for single-use or reusable applications?
The KeyDenture Base is supplied as a reusable material in 1 kg packs, intended for use in dental laboratories. It is not sterile at the time of supply and must be processed according to standard dental laboratory protocols before patient use. This design ensures durability and cost-effectiveness for repeated use in denture fabrication.
How should the KeyDenture Base be stored to maintain its integrity?
The KeyDenture Base should be stored following the manufacturer’s guidelines to preserve its material integrity. While specific storage conditions are not detailed, proper handling—such as keeping it in a clean, dry environment away from direct sunlight or extreme temperatures—is recommended to prevent degradation before processing.
What are the key differences in supply packaging for the KeyDenture Base?
The KeyDenture Base is supplied in 1 kg packs with the reference code 4220430. Each pack is intended for dental laboratory use and is not sterile at the time of supply, requiring standard laboratory processing before clinical application. The reusable nature of the material is emphasized for efficient workflows in denture fabrication.
How was the FDA clearance for the KeyDenture Base determined?
The KeyPrint KeyDenture Base received FDA clearance through a Traditional 510(k) pathway (K241089), where it was deemed substantially equivalent to predicate devices. This classification falls under the Denture Base (Product Code: EBI) category, adhering to dental regulatory standards as reviewed by the Dental (DE) Advisory Committee.
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: KeyDenture® - KeyPrint, PDF KeyDenture Base - keyprint.keystoneindustries.com, KEYSTONE KeyPRINT KeyDenture Base Original 1kg 1-Pack | KEYSTONE ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241089 | Class II | Active |
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Manufacturer
- Manufacturer
- Keystone Industries
Sources (1)
- FDA 510(k) K241089 24 fields · synced Sep 20, 2026