NB Regular Kit

GUDID 08800341412454

ARUM DENTISTRY Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID08800341412454
NIH Device Record Key28994092-a2b0-4265-ac8c-5d213507c7c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameNB Regular Kit
Version Model NumberREK2C-SET
Company DUNS557821945
Company NameARUM DENTISTRY Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
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
GS108800341412454 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800341412454]

Moist Heat or Steam Sterilization


[08800341412454]

Moist Heat or Steam Sterilization


[08800341412454]

Moist Heat or Steam Sterilization


[08800341412454]

Moist Heat or Steam Sterilization


[08800341412454]

Moist Heat or Steam Sterilization


[08800341412454]

Moist Heat or Steam Sterilization


[08800341412454]

Moist Heat or Steam Sterilization


[08800341412454]

Moist Heat or Steam Sterilization


[08800341412454]

Moist Heat or Steam Sterilization


[08800341412454]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-04-01
Device Publish Date2026-03-24

On-Brand Devices [NB Regular Kit ]

08809982750802REK2-SET
08800341412454REK2C-SET
08800055791210REK-SET

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.