FDA.reportPublic FDA data

TruScan Body Kit

Primary DI
08800076465367
Brand
TruScan Body Kit
Company
Truabutment Korea Co.,Ltd
Model
BC34-PSBCASE-VT
Published
2026-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800076465367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800076465367088000764653678800076465367

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant kitA collection of prefabricated dental devices and components, which includes a dental implant, intended to be used during dental surgery and laboratory procedures to create and implant the foundation of a reconstructed tooth. In addition to the dental implant, it includes a dental abutment(s) (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), and additional components to facilitate restoration (e.g., abutment analog, abutment impression cap). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694514760
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800076412484AOT Scan BodyAOT-SBLU2026-03-19
08800076412491AOT Scan BodyAOT-SBLH2026-03-19
08800076412507AOT Scan BodyAOT-SBLH122026-03-19
08800076412514AOT Scan BodyAOT-SBLT2026-03-19
08800076475625MOD RetractorPYFDRRCL2026-05-11
08800076475649ioConnect ScrewIOW1602H122026-05-11
08800076402607Basic AbutmentUDA4517N2026-04-30
08800076402614Basic AbutmentUDA4527N2026-04-30
08800076402621Basic AbutmentUDA4537N2026-04-30
08800076402638Basic AbutmentUDA4547N2026-04-30
08800076402645Basic AbutmentUDA4557N2026-04-30
08800076402652Basic AbutmentUDA4567N2026-04-30
08800076402782Basic AbutmentUDA5517N2026-04-30
08800076402799Basic AbutmentUDA5527N2026-04-30
08800076402805Basic AbutmentUDA5537N2026-04-30
08800076402812Basic AbutmentUDA5547N2026-04-30
08800076402829Basic AbutmentUDA5557N2026-04-30
08800076402836Basic AbutmentUDA5567N2026-04-30
08800076402966Basic AbutmentUDA6517N2026-04-30
08800076402973Basic AbutmentUDA6527N2026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235312DRIVER HANDPIECE MINI ABUT. MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235329DRIVER RATCHET ABUT. HEX 2MM EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235343DRIVER RATCHET ABUT. HEX 2MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235367DRIVER RATCHET ABUT. HEX 2MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235374DRIVER RATCHET ABUT. HEX 2MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235381DRIVER RATCHET ABUT. HEX 2MM EXT. SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235503DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235510DRIVER RATCHET RETRIVER M1.8MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235527DRIVER RATCHET RETRIVER M1.8MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235534DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235565DRIVER RATCHET RETRIVER M1.6MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
00815967026143RodinPac-Dent, Inc.NDP2026-07-13
00815967029403RodinPac-Dent, Inc.NDP2026-07-13
06942799000004SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000035SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000042SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000073SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000080SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000110SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNDP2026-07-13
07290109748054Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748061Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748078Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748085Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748092Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748108Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748115Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290116660882Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12