TRUST Dental Abutment Software by Rgorithm Korea

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK221107	Date18 Jul 2023Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K221107

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name: Trust

510(k) Number: K221107
FDA product code: PNP

Device class: Class II
Regulation: 21 CFR Part 872.3630
Advisory committee: Dental
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Abutment Design K200100 7 Oct 2020 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Devices cleared under K221107

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K221107
		UDI-DI	Size and differences
TRUST V1.0 Rgorithm Korea	V1.0	08809965590005	—	On the market

Similar devices

Other devices filed under FDA product code PNP (Dental Abutment Design Software For Dental Laboratory).

Other devices from Rgorithm Korea

Trust V1.0

Class II