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510(k) Data Aggregation
K Number
K221107Device Name
TRUST
Manufacturer
Rgorithm Korea
Date Cleared
2023-07-18
(459 days)
Product Code
PNP
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
Rgorithm Korea
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxillae. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
Device Description
TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxilla. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
TRUST is restricted to be used with 510(k) cleared abutment systems, and the design output from TRUST (the patient specific part of the abutment) must be manufactured according to the instruction of the selected Implant system.
TRUST includes design parameters from the 510(k) cleared abutment systems such as implant type, maximum and minimum dimensions (e.g., abutment post height, angulation, gingival marqin diameter, wall thickness). The design parameters, provided by abutment system manufacturers(Truabutment), for an abutment system are available via a Trust server when documentation of the 510(k) clearance of said implant system is confirmed by Rgorithm.
TRUST has no patient contact being a software only device. (stand-alone software)
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