NB I Fixture

GUDID 08809917605238

ARUM DENTISTRY Co., Ltd.

Screw endosteal dental implant, two-piece
Primary Device ID08809917605238
NIH Device Record Keyfb0b89fb-a5c8-4223-9552-bd6c2a38576a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNB I Fixture
Version Model NumberNB16013SS
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
GS108809917605238 [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 Date2025-01-28
Device Publish Date2025-01-20

On-Brand Devices [NB I Fixture]

08809917605290NB16513SS
08809917605283NB16511SS
08809917605276NB16510SS
08809917605269NB16508SS
08809917605252NB16507SS
08809917605245NB16506SS
08809917605238NB16013SS
08809917605221NB16011SS
08809917605214NB16010SS
08809917605207NB16008SS
08809917605191NB16007SS
08809917605184NB16006SS
08809917605177NB15513SS
08809917605160NB15511SS
08809917605153NB15510SS
08809917605146NB15508SS
08809917605122NB15506SS
08809917605115NB15007SS
08809917605108NB14507SS
08809917605092NB14007SS
08809917605085NB15013SS
08809917605078NB15011SS
08809917605061NB15010SS
08809917605054NB15008SS
08809917605047NB14513SS
08809917605030NB14511SS
08809917605023NB14510SS
08809917605016NB14508SS
08809917605009NB14013SS
08809917604996NB14011SS
08809917604989NB14010SS
08809917604972NB14008SS
08800055794594NB16513SP
08800055794587NB16511SP
08800055794570NB16510SP
08800055794563NB16508SP
08800055794556NB16507SP
08800055794549NB16506SP
08800055794532NB16013SP
08800055794525NB16011SP
08800055794518NB16010SP
08800055794501NB16008SP
08800055794495NB16007SP
08800055794488NB16006SP
08800055794471NB15513SP
08800055794464NB15511SP
08800055794457NB15510SP
08800055794440NB15508SP
08800055794433NB15507SP
08800055794426NB15506SP

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.