ARENA Star

GUDID 08800055731346

ARUM DENTISTRY Co., Ltd.

Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic
Primary Device ID08800055731346
NIH Device Record Key992a8cae-ba1e-4af2-8e6e-fba5e554a94d
Commercial Distribution StatusIn Commercial Distribution
Brand NameARENA Star
Version Model NumberArum-DR-22-ML3
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
GS108800055731346 [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 Date2023-04-12
Device Publish Date2023-04-04

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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