Twin-Zero Screw

GUDID 08809982751342

ARUM DENTISTRY Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08809982751342
NIH Device Record Keyd15b93e5-6576-4c44-87cb-f67eb1421486
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwin-Zero Screw
Version Model NumberYTAS43R
Company DUNS557821945
Company NameARUM DENTISTRY 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 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
GS108809982751342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809982751342]

Moist Heat or Steam Sterilization


[08809982751342]

Moist Heat or Steam Sterilization


[08809982751342]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-16
Device Publish Date2026-02-06

On-Brand Devices [Twin-Zero Screw]

08809982751403YTAS55R
08809982751397YTAS45R
08809982751380YTAS35R
08809982751373YTAS25R
08809982751366YTAS15R
08809982751359YTAS53R
08809982751342YTAS43R
08809982751335YTAS33R
08809982751328YTAS23R
08809982751311YTAS13R

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