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Denture Base Resin DT20

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250946

by Hangzhou SHINING3D Dental Technology Co., Ltd.

Identifiers

510(k) Number
K250946 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)

Denture Base Resin DT20 is a dental device classified under product code EBI, intended for use in dental applications. It is a resin material designed for the fabrication of denture base components.

The device is supplied as a non-sterile, single-use material for use in dental laboratories or clinical settings. It has received FDA 510(k) clearance (K250946) and is classified as a Class II device. Storage and handling should follow manufacturer guidelines, though specific conditions are not detailed in the provided data.

Frequently asked questions

What is Denture Base Resin DT20 used for?

Denture Base Resin DT20 is intended for the fabrication of denture base components in dental applications, as specified in its product code EBI classification, and is designed for use in dental laboratories or clinical settings.

Is Denture Base Resin DT20 sterile or single-use?

The device is supplied as a non-sterile, single-use material, meaning it is not provided in a sterile condition and is intended for one-time use only during the denture fabrication process.

How is Denture Base Resin DT20 supplied and stored?

Denture Base Resin DT20 is supplied as a resin material for dental use, and while storage and handling should follow manufacturer guidelines, specific storage conditions are not detailed in the provided device data.

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: Shining 3D Denture Base DT20 | Dental Resin | bm3d, Denture Base Resin DT20 (K250946) — FDA 510 (k) | Innolitics, DT20 : Dental Support, Denture Base Resin DT20 | Shining 3D

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hangzhou SHINING3D Dental Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K250946 24 fields · synced Oct 6, 2026