NB II Fixture

GUDID 08809917605368

ARUM DENTISTRY Co., Ltd.

Screw endosteal dental implant, two-piece
Primary Device ID08809917605368
NIH Device Record Key604c90c1-2d79-4554-85e1-2d62c211b501
Commercial Distribution StatusIn Commercial Distribution
Brand NameNB II Fixture
Version Model NumberNB24508SS
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809917605368 [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 Date2023-07-13
Device Publish Date2023-07-05

On-Brand Devices [NB II Fixture]

08809917605597NB26513SS
08809917605580NB26511SS
08809917605573NB26510SS
08809917605566NB26508SS
08809917605559NB26507SS
08809917605542NB26013SS
08809917605535NB26011SS
08809917605528NB26010SS
08809917605511NB26008SS
08809917605504NB26007SS
08809917605498NB25513SS
08809917605481NB25511SS
08809917605474NB25510SS
08809917605467NB25508SS
08809917605450NB25507SS
08809917605443NB25013SS
08809917605436NB25011SS
08809917605429NB25010SS
08809917605412NB25008SS
08809917605405NB25007SS
08809917605399NB24513SS
08809917605382NB24511SS
08809917605375NB24510SS
08809917605368NB24508SS
08809917605351NB24507SS
08809917605344NB24013SS
08809917605337NB24011SS
08809917605320NB24010SS
08809917605313NB24008SS
08809917605306NB24007SS
08800055777948NB26513SP
08800055777931NB26511SP
08800055777924NB26510SP
08800055777917NB26508SP
08800055777900NB26507SP
08800055777894NB26013SP
08800055777887NB26011SP
08800055777870NB26010SP
08800055777863NB26008SP
08800055777856NB26007SP
08800055777849NB25513SP
08800055777832NB25511SP
08800055777825NB25510SP
08800055777818NB25508SP
08800055777801NB25507SP
08800055777795NB25013SP
08800055777788NB25011SP
08800055777771NB25010SP
08800055777764NB25008SP
08800055777757NB25007SP

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