ARENA Star

GUDID 08800055732862

ARUM DENTISTRY Co., Ltd.

Dental appliance fabrication material, ceramic
Primary Device ID08800055732862
NIH Device Record Key04e50a74-1324-4964-bf7c-c3a4e89a9c0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameARENA Star
Version Model NumberArum-WR-22-C1
Company DUNS557821945
Company NameARUM DENTISTRY Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800055732862 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-10
Device Publish Date2023-03-31

On-Brand Devices [ARENA Star]

08800055732008Arum-WR-10-A2
08800055731902Arum-WR-10-A1
08800055731803Arum-WR-10
08800055733494Arum-WR-30-D4
08800055733487Arum-WR-28-D4
08800055733470Arum-WR-25-D4
08800055733463Arum-WR-22-D4
08800055733456Arum-WR-20-D4
08800055733449Arum-WR-18-D4
08800055733432Arum-WR-16-D4
08800055733425Arum-WR-14-D4
08800055733418Arum-WR-12-D4
08800055733401Arum-WR-10-D4
08800055733395Arum-WR-30-D3
08800055733388Arum-WR-28-D3
08800055733371Arum-WR-25-D3
08800055733364Arum-WR-22-D3
08800055733357Arum-WR-20-D3
08800055733340Arum-WR-18-D3
08800055733333Arum-WR-16-D3
08800055733326Arum-WR-14-D3
08800055733319Arum-WR-12-D3
08800055733302Arum-WR-10-D3
08800055733296Arum-WR-30-D2
08800055733289Arum-WR-28-D2
08800055733272Arum-WR-25-D2
08800055733265Arum-WR-22-D2
08800055733258Arum-WR-20-D2
08800055733241Arum-WR-18-D2
08800055733234Arum-WR-16-D2
08800055733227Arum-WR-14-D2
08800055733210Arum-WR-12-D2
08800055733203Arum-WR-10-D2
08800055733197Arum-WR-30-C4
08800055733180Arum-WR-28-C4
08800055733173Arum-WR-25-C4
08800055733166Arum-WR-22-C4
08800055733159Arum-WR-20-C4
08800055733142Arum-WR-18-C4
08800055733135Arum-WR-16-C4
08800055733128Arum-WR-14-C4
08800055733111Arum-WR-12-C4
08800055733104Arum-WR-10-C4
08800055733098Arum-WR-30-C3
08800055733081Arum-WR-28-C3
08800055733074Arum-WR-25-C3
08800055733067Arum-WR-22-C3
08800055733050Arum-WR-20-C3
08800055733043Arum-WR-18-C3
08800055733036Arum-WR-16-C3

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