TRUST

Primary DI
08809965590005
Brand
TRUST
Company
Rgorithm Korea
Model
V1.0
Device description
TRUST Dental CAD Software
Published
2023-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNPDental Abutment Design Software For Dental Laboratory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNPDental Abutment Design Software For Dental LaboratoryDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221107000TRUSTRgorithm Korea2023-07-18PNP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809965590005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809965590005088099655900058809965590005

GMDN Terms#

Term, Definition table
TermDefinition
CAD/CAM softwareA software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82262644688kihyun.hong@truabutment.com

Regulatory Flags#

DUNS number
695116627
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00847236027797BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027803BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027810BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027827BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027834BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027841BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027896BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027902BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027919BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027926BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
04260521363633Ceramill M-Plantexocad GmbHPNP2026-02-02
08435566638831IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638848IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638855IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638862IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638893IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638923IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638930IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638978IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638985IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638992IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639005IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639012IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639029IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639036IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639111IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639128IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639166IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639173IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639180IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30