URIS All-on-X Pro Kit

GUDID 08800076435827

Truabutment Korea Co.,Ltd

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID08800076435827
NIH Device Record Keyffb42de3-6009-4386-aaca-11c3e9b60ed8
Commercial Distribution StatusIn Commercial Distribution
Brand NameURIS All-on-X Pro Kit
Version Model NumberXPK01
Company DUNS694514760
Company NameTruabutment Korea Co.,Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800076435827 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


[08800076435827]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-03
Device Publish Date2026-02-23

Devices Manufactured by Truabutment Korea Co.,Ltd

08800076466111 - Square Spanner2026-03-05
08800076410220 - Impression Post Transfer Type Screw2026-03-03
08800076410237 - Impression Post Transfer Type Screw2026-03-03
08800076410244 - Impression Post Transfer Type Screw2026-03-03
08800076410251 - Impression Post Transfer Type Screw2026-03-03
08800076435827 - URIS All-on-X Pro Kit2026-03-03
08800076435827 - URIS All-on-X Pro Kit2026-03-03
08800076451681 - AOT Plus Impression Screw2026-03-03
08800076451698 - AOT Plus Impression Screw2026-03-03

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