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Apex Flex

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250617

by Sprintray, Inc.

Identifiers

510(k) Number
K250617 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 Apex Flex Partial Base is a biocompatible resin designed for 3D printing flexible partial denture bases. Classified as a dental resin under the FDA’s Dental advisory committee, it is intended for use in fabricating removable partial dentures with enhanced flexibility and patient comfort. Its formulation supports natural-looking, durable restorations tailored for in-office production.

Supplied as a 500g resin in Light Pink shade, the Apex Flex Partial Base is compatible with the SprintRay Apex teeth system for seamless integration within the manufacturer’s 3D printing workflow. It is single-use and requires no sterilization, intended exclusively for dental laboratory or clinical use. Authorized under FDA 510(k) clearance (K250617), the device adheres to traditional review standards for dental materials.

Frequently asked questions

What types of dental restorations can the Apex Flex Partial Base be used to create, and how does its flexibility benefit patients?

The Apex Flex Partial Base is specifically designed for fabricating removable partial denture bases using 3D printing technology. Its flexible formulation enhances patient comfort by reducing pressure points and improving adaptability to the oral environment, which is particularly useful for long-term wear or areas with limited space.

Is the Apex Flex Partial Base compatible with other dental materials, and how is it integrated into the manufacturing process?

Yes, the Apex Flex Partial Base is formulated to work seamlessly with the SprintRay Apex teeth system, allowing for cohesive in-office production of partial dentures. This compatibility ensures a streamlined workflow for dental labs and clinicians, enabling natural-looking restorations with enhanced flexibility.

How is the Apex Flex Partial Base supplied, and what should buyers consider regarding its usage and disposal?

The Apex Flex Partial Base comes as a 500g resin in a light pink shade, intended for single-use only. Since it is not sterilizable, each unit is designed for one-time fabrication of a partial denture base. Buyers should account for this in their workflow planning, ensuring proper inventory management for clinical or laboratory use.

What storage conditions are recommended for the Apex Flex Partial Base to maintain its integrity?

While the exact storage conditions aren’t detailed in the provided data, biocompatible resins like the Apex Flex Partial Base typically require protection from moisture, extreme temperatures, and direct sunlight. Buyers should store it in a sealed, dry environment as per the manufacturer’s guidelines to preserve its performance for 3D printing applications.

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: The Apex Portfolio Just Got a New Superpower | Sprintray, Design and 3D Print Flexible Partial Dentures - SprintRay Inc., SprintRay Apex Flex Partial Base - Light Pink - 500g

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sprintray, Inc.

Sources (1)

  • FDA 510(k) K250617 24 fields · synced Sep 19, 2026