FDA.report

TruLab Analog

Primary DI
08800076412811
Brand
TruLab Analog
Company
Truabutment Korea Co.,Ltd
Model
AE42-LA
Published
2026-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800076412811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800076412811088000764128118800076412811

GMDN Terms

TermDefinition
Dental implant analogA device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
694514760
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800076409989Impression Post Pick-Up Type ScrewUIPPNS152026-03-24
08800076409996Impression Post Pick-Up Type ScrewUIPPNS192026-03-24
08800076410008Impression Post Pick-Up Type ScrewUIPPNS212026-03-24
08800076410015Impression Post Pick-Up Type ScrewUIPPNS252026-03-24
08800076410022Impression Post Pick-Up Type ScrewUIPPS162026-03-24
08800076410039Impression Post Pick-Up Type ScrewUIPPS202026-03-24
08800076410046Impression Post Pick-Up Type ScrewUIPPS222026-03-24
08800076410053Impression Post Pick-Up Type ScrewUIPPS262026-03-24
08800076414440AOT Digital AnalogCMM-ATDLA2026-03-24
08800076414662Multi-Unit Burn Out CylinderUMBC50H2026-03-24
08800076414679Multi-Unit Burn Out CylinderUMBC50N2026-03-24
08800076418073Drill ExtensionDEH45142026-03-24
08800076423664URIS Scan PostUSPN40182026-03-24
08800076423671URIS Scan PostUSPN40282026-03-24
08800076423688URIS Scan PostUSPN40382026-03-24
08800076423695URIS Scan PostUSPR45082026-03-24
08800076423701URIS Scan PostUSPR45182026-03-24
08800076423718URIS Scan PostUSPR45282026-03-24
08800076423725URIS Scan PostUSPR45382026-03-24
08800076423756TruScan Post Kit CaseBHN-SBCASE2026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08056591027355JDEvolution SJ DENTAL CARE SRLNDP2026-05-25
00840481135408LOCATORZest Anchors, LLCNDP2026-05-22
00840481135972LOCATORZest Anchors, LLCNDP2026-05-22
00840481138065LOCATOR R-TXZest Anchors, LLCNDP2026-05-22
08800020806123O-RING LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-22
08800020819024HEX WRENCH DRIVERSNUCONE Co.,LTD.NDP2026-05-22
08800020849052HEX WRENCH DRIVERSNUCONE Co.,LTD.NDP2026-05-22
08800020853462HANDPIECE HEX DRIVERSNUCONE Co.,LTD.NDP2026-05-22
08800020856661ABIDING MU SCANBODYSNUCONE Co.,LTD.NDP2026-05-22
08800020856685ABIDING Ti SCANBODYSNUCONE Co.,LTD.NDP2026-05-22
08800020856692ABIDING Ti SCANBODYSNUCONE Co.,LTD.NDP2026-05-22
08800020856708ABIDING Ti SCANBODYSNUCONE Co.,LTD.NDP2026-05-22
08800020856715ABIDING Ti SCANBODYSNUCONE Co.,LTD.NDP2026-05-22
08800020856722ABIDING Ti SCANBODY SCREWSNUCONE Co.,LTD.NDP2026-05-22
08800020856739ABIDING Ti SCANBODY SCREWSNUCONE Co.,LTD.NDP2026-05-22
08800020856746ABIDING Ti SCANBODY SCREWSNUCONE Co.,LTD.NDP2026-05-22
08800020856753ABIDING Ti SCANBODY SCREWSNUCONE Co.,LTD.NDP2026-05-22
08800020858955GUIDE FIXTURE DRIVER C-RingSNUCONE Co.,LTD.NDP2026-05-22
08800020858962GUIDE FIXTURE DRIVER C-RingSNUCONE Co.,LTD.NDP2026-05-22
08800020858979GUIDE FIXTURE DRIVER C-RingSNUCONE Co.,LTD.NDP2026-05-22
08800020858986GUIDE FIXTURE DRIVER C-RingSNUCONE Co.,LTD.NDP2026-05-22
08800020858993GUIDE FIXTURE WRENCH DRIVER C-RingSNUCONE Co.,LTD.NDP2026-05-22
08800020859006GUIDE FIXTURE WRENCH DRIVER C-RingSNUCONE Co.,LTD.NDP2026-05-22
08800020859013GUIDE FIXTURE WRENCH DRIVER C-RingSNUCONE Co.,LTD.NDP2026-05-22
08800020859020GUIDE FIXTURE WRENCH DRIVER C-RingSNUCONE Co.,LTD.NDP2026-05-22
08800020859037FIXTURE GRIP DRIVER C-RingSNUCONE Co.,LTD.NDP2026-05-22
08800020859044FIXTURE GRIP DRIVER C-RingSNUCONE Co.,LTD.NDP2026-05-22
08800020859051FIXTURE GRIP DRIVER C-RingSNUCONE Co.,LTD.NDP2026-05-22
08800020859068FIXTURE GRIP DRIVER C-RingSNUCONE Co.,LTD.NDP2026-05-22
08800020859075FIXTURE GRIP DRIVER C-RingSNUCONE Co.,LTD.NDP2026-05-22