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TRUST Dental Abutment Design Software

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221107

by Rgorithm Korea

Identifiers

510(k) Number
K221107 FDA 510(k)
FDA Product Code
PNP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3630 FDA 510(k)
Regulation Number
872.3630 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

TRUST is a Dental Abutment Design Software used in dental laboratories for creating custom dental abutments and crown designs. It leverages split-file technology to facilitate precise digital workflows, enabling technicians to generate patient-specific restorations from TruScan Body scans. The software integrates design flexibility, allowing modifications to abutment and crown geometries as needed for clinical requirements.

TRUST is supplied as a standalone software application requiring an Intel i3 Dual Core CPU and 2 GB of free hard disk space for operation. It is not sterile and is intended for single-use per design project, with updates managed by the manufacturer via periodic releases. The device holds FDA 510(k) clearance (K221107) under Dental (DE) Advisory Committee classification, adhering to 21 CFR 872.3630 for dental software. No third-party reprocessing or sterilisation is applicable.

Frequently asked questions

What is the primary purpose of the TRUST software in a dental laboratory workflow?

TRUST is a dental abutment design software designed specifically for dental laboratories to create custom dental abutments and crowns. It uses split-file technology to enable precise digital workflows, allowing technicians to generate patient-specific restorations from TruScan Body scans. The software provides design flexibility to modify abutment and crown geometries as needed to meet clinical requirements.

How is the TRUST software supplied, and what are its minimum system requirements?

TRUST is supplied as a standalone software application. To operate, it requires an Intel i3 Dual Core CPU and at least 2 GB of free hard disk space. It is not a physical device and does not require sterilization, as it is a digital tool used for design purposes.

Is the TRUST software intended for reuse across multiple projects, or is it single-use?

TRUST is intended for single-use per design project. Each project involves creating custom abutments or crowns, and the software is not designed to be reused in the same way as a physical device. Updates are managed by the manufacturer through periodic software releases.

What regulatory pathway was followed for the TRUST software, and what classification does it hold?

TRUST holds FDA 510(k) clearance (K221107) under the Dental (DE) Advisory Committee classification. It was determined to be substantially equivalent to a predicate device and adheres to 21 CFR 872.3630, which governs dental software. The device is classified as Class II under the FDA’s regulatory framework.

Can the TRUST software be reprocessed or sterilized, or is it intended for one-time use in a digital workflow?

TRUST is not applicable for third-party reprocessing or sterilization, as it is a software application rather than a physical medical device. It operates in a digital workflow and is intended for single-use per design project, with updates provided by the manufacturer through periodic software releases.

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: K221107 - TRUST | FDA 510(k) | Rgorithm Korea, Support│TruSuite, Home | Rgorithm, Support│TruSuite

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Rgorithm Korea

Sources (1)

  • FDA 510(k) K221107 24 fields · synced Sep 19, 2026