Smart Path extra aggressive Thread Fixture

GUDID 08800076444638

Truabutment Korea Co.,Ltd

Screw endosteal dental implant, two-piece
Primary Device ID08800076444638
NIH Device Record Keyd6417d37-232d-47d2-8bbb-90d644761486
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmart Path extra aggressive Thread Fixture
Version Model NumberSPXT4553130
Company DUNS694514760
Company NameTruabutment Korea Co.,Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800076444638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-03
Device Publish Date2026-01-26

On-Brand Devices [Smart Path extra aggressive Thread Fixture]

08800076444690SPXT5563085
08800076444683SPXT5563070
08800076444669SPXT5559085
08800076444652SPXT5559070
08800076444645SPXT4553145
08800076444638SPXT4553130
08800076444621SPXT4553115
08800076444607SPXT4553085
08800076444591SPXT4553070
08800076444584SPXT4549145
08800076444577SPXT4549130
08800076444560SPXT4549115
08800076444546SPXT4549085
08800076444539SPXT4549070
08800076444522SPXT3543145
08800076444515SPXT3543130
08800076444508SPXT3543115
08800076444485SPXT3543085
08800076444478SPXT3543070
08800076444461SPXT3539145
08800076444454SPXT3539130
08800076444447SPXT3539115
08800076444423SPXT3539085
08800076444416SPXT3539070

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