NB Fixture Mini

GUDID 08800055751283

ARUM DENTISTRY Co., Ltd.

Screw endosteal dental implant, two-piece
Primary Device ID08800055751283
NIH Device Record Key6542805a-7454-4960-8ccc-8937e0a56621
Commercial Distribution StatusIn Commercial Distribution
Brand NameNB Fixture Mini
Version Model NumberNB3511SP
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
GS108800055751283 [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 Date2024-05-13
Device Publish Date2024-05-03

On-Brand Devices [NB Fixture Mini ]

08809924580788NB3513SS
08809917609786NB3513SP
08809917609779NB3511SS
08809917609762NB3510SS
08809917609755NB3508SS
08809917609748NB3213SS
08809917609731NB3211SS
08809917609724NB3210SS
08809917609717NB3208SS
08800055751283NB3511SP
08800055751276NB3510SP
08800055751269NB3508SP
08800055751252NB3213SP
08800055751245NB3211SP
08800055751238NB3210SP
08800055751221NB3208SP

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