FDA.reportPublic FDA data

ARENA Star

Primary DI
08800055732985
Brand
ARENA Star
Company
ARUM DENTISTRY Co., Ltd.
Model
Arum-WR-28-C2
Published
2023-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DIHColorimetry, Cholinesterase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIHColorimetry, CholinesteraseClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223253000Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)Arum Dentistry Co., Ltd.2023-02-27EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800055732985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800055732985088000557329858800055732985

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557821945
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800055715605Pre-milled BlankCIHE0232026-03-12
08800055715612Pre-milled BlankCIHE0242026-03-12
08800055715629Pre-milled BlankCIHE0252026-03-12
08800055715636Pre-milled BlankCIHE0262026-03-12
08800055715865Pre-milled BlankCIHE0532026-03-12
08800055715872Pre-milled BlankCIHE0542026-03-12
08800055715889Pre-milled BlankCIHE0552026-03-12
08800055715896Pre-milled BlankCIHE0562026-03-12
08800055715902Pre-milled BlankCIHE0572026-03-12
08800055715919Pre-milled BlankCIHE0582026-03-12
08800055716282Pre-milled BlankCIHE0952026-03-12
08800055716299Pre-milled BlankCIHE0962026-03-12
08800055716305Pre-milled BlankCIHE0972026-03-12
08800055716312Pre-milled BlankCIHE0982026-03-12
08800055716329Pre-milled BlankCIHE0992026-03-12
08800055716336Pre-milled BlankCIHE1002026-03-12
08800055746128Pre-milled BlankCIHE2012026-03-12
08800055746135Pre-milled BlankCIHE2022026-03-12
08800055762067Pre-milled BlankCIHE023P2026-03-12
08800055762074Pre-milled BlankCIHE024P2026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010612200Test-mate ChE Cholinesterase Test SystemEqm Research, Inc.DIH2023-07-31
00860010612217AChE Assay KitEqm Research, Inc.DIH2023-07-31
00860010612224PChE Assay KitEqm Research, Inc.DIH2023-07-31
10673486001488Teco Diagnostics Cholinesterase Reagent SetTECO DIAGNOSTICSDIH2023-07-26
06971674862932BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862949BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862956BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862963BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862970BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862987BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862994BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863007BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863014BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863021BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863038BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863045BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863052BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
00630414611044Atellica CH Cholinesterase_2Siemens Healthcare Diagnostics Inc.DIH2023-06-29
00630414305042Atellica CH Cholinesterase_2Siemens Healthcare Diagnostics Inc.DIH2023-06-29
04015630991549CholinesteraseRoche Diagnostics GmbHDIH2021-06-28
04015630920945Cholinesterase Gen.2Roche Diagnostics GmbHDIH2021-01-18
00630414465401ADVIA® Chemistry CHE Cholinesterase ReagentsSiemens Healthcare Diagnostics Inc.DIH2020-09-24
00630414510149ADVIA® Chemistry CHE Cholinesterase ReagentsSiemens Healthcare Diagnostics Inc.DIH2020-09-24
00630414596273Atellica CH CHESiemens Healthcare Diagnostics Inc.DIH2020-09-24
00842768014178Dimension® Flex® reagent cartridge PCHESiemens Healthcare Diagnostics Inc.DIH2020-09-24
00842768015373Dimension Vista® Flex® reagent cartridge PCHESiemens Healthcare Diagnostics Inc.DIH2020-09-24
10758750000241VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DIH2020-04-18
10758750004225VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DIH2020-04-18
07613336133620Cholinesterase Gen.2Roche Diagnostics GmbHDIH2020-03-05
05055273201093BUTYRYL CHOLINESTERASE (CHE)RANDOX LABORATORIES LIMITEDDIH2019-06-03