Cleared Traditional

TRUST

K221107 · Rgorithm Korea · Dental
Jul 2023
Decision
459d
Days
Class 2
Risk

About This 510(k) Submission

K221107 is an FDA 510(k) clearance for the TRUST, a Dental Abutment Design Software For Dental Laboratory (Class II — Special Controls, product code PNP), submitted by Rgorithm Korea (Geumcheon-Gu, KR). The FDA issued a Cleared decision on July 18, 2023, 459 days after receiving the submission on April 15, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number K221107 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2022
Decision Date July 18, 2023
Days to Decision 459 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code PNP — Dental Abutment Design Software For Dental Laboratory
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3630
Definition The Device Is Intended To Aid In The Restoration Of Chewing Function By Allowing A Dental Laboratory Or Dental Clinician To Design The Patient-specific Component Of A Dental Abutment (i.e. Abutment Collar And Abutment Post) And Cam Or Create That Component At A Dental Office Or Dental Laboratory Following The Directions Of The Dental Implant System. The Abutment-to-implant Interface/connection Platform Is Not A Patient-specific Component Of The Dental Abutment.