ARENA Star

GUDID 08800055760186

ARUM DENTISTRY Co., Ltd.

Dental appliance fabrication material, ceramic
Primary Device ID08800055760186
NIH Device Record Key2e59f514-e4e9-4489-9142-726a3da64d9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameARENA Star
Version Model NumberAML516A2-WR
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
GS108800055760186 [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 Date2023-04-11
Device Publish Date2023-04-03

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

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