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SprintRay Denture Base

FDA 510(k)

Class II (US FDA 510(k))

510(k) K220979

by Sprintray, Inc.

Identifiers

510(k) Number
K220979 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 SprintRay Denture Base is a removable dental prosthesis base designed for 3D printing, intended to support removable or partial dentures. Classified under the product code EBI, it is engineered to provide a durable foundation for dental restorations, ensuring compatibility with digital dentistry workflows. This device is specifically tailored for use in dental laboratories or clinics where custom dentures are fabricated.

Supplied as a resin material, the SprintRay Denture Base is intended for single-use applications in dental prosthetics. It is cleared by the FDA under the 510(k) pathway as substantially equivalent to existing dental base materials. The device adheres to high-impact ISO standards for mechanical properties, ensuring reliability and structural integrity. Storage and handling follow standard dental laboratory protocols, with no specific MRI safety considerations noted.

Frequently asked questions

What types of dental restorations can the SprintRay Denture Base support, and how does it integrate with digital dentistry workflows?

The SprintRay Denture Base is specifically designed to support removable or partial dentures, providing a durable foundation for dental restorations. It is engineered for compatibility with digital dentistry workflows, meaning it can be fabricated using 3D printing technology in dental laboratories or clinics. This makes it ideal for custom fabrication processes where precision and efficiency are key.

Is the SprintRay Denture Base intended for reuse, or is it meant to be used only once?

The SprintRay Denture Base is supplied as a resin material and is explicitly intended for single-use applications in dental prosthetics. This aligns with standard practices for removable dental prostheses to ensure patient safety and hygiene.

What storage and handling guidelines should be followed for the SprintRay Denture Base?

The SprintRay Denture Base follows standard dental laboratory protocols for storage and handling. Since it is a resin-based 3D-printed material, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. No specific MRI safety considerations are noted, but general laboratory hygiene practices should be maintained to preserve its integrity and functionality.

What mechanical properties does the SprintRay Denture Base meet, and how does this ensure reliability?

The SprintRay Denture Base adheres to high-impact ISO standards for mechanical properties, ensuring it maintains structural integrity and durability under typical dental use. This certification guarantees it can withstand the forces exerted during chewing and daily wear, providing a reliable foundation for removable or partial dentures.

How was the FDA clearance for the SprintRay Denture Base determined, and what does this mean for its use in clinical settings?

The SprintRay Denture Base was cleared by the FDA under the 510(k) pathway, with a decision code of SESE (Substantially Equivalent). This means it was determined to be substantially equivalent to existing dental base materials already on the market, ensuring it meets regulatory standards for safety and effectiveness. Clinicians can rely on this clearance as confirmation that the device adheres to established benchmarks for removable dental prostheses.

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: Design and 3D Print Removable Dentures - SprintRay Inc., 3D Printing Solutions for Digital Dentistry - SprintRay Inc, Dentures - SprintRay Store, SprintRay Apex Base - Light Pink - 1 Kg - SprintRay Store

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sprintray, Inc.

Sources (1)

  • FDA 510(k) K220979 24 fields · synced Sep 20, 2026