Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TRUST

K-Number: K221107 · 2023-07-18

ApplicantRgorithm Korea
Decision Date2023-07-18
Product CodePNP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRUST is the device name listed in this FDA 510(k) record. The listed applicant is Rgorithm Korea. It received FDA 510(k) clearance on 2023-07-18 under 510(k) number K221107. The device is classified under product code PNP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUST?

TRUST is a medical device that received FDA 510(k) clearance on 2023-07-18. The listed applicant is Rgorithm Korea. The 510(k) number is K221107.

When did TRUST receive FDA 510(k) clearance?

TRUST received FDA 510(k) clearance on 2023-07-18, under 510(k) number K221107.

Who is the listed applicant for TRUST?

The FDA 510(k) record lists Rgorithm Korea as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUST?

The FDA product code for TRUST is PNP.

Related Devices (Code: PNP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AGK231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.K193352AbutmentCADExocad GmbHK200100Abutment Design3Shape A/SK200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply SironaK181932DTX Studio designNobel Biocare AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑