FDA.reportPublic FDA data

LUXEN 5G

Primary DI
08809900540171
Brand
LUXEN 5G
Company
DENTALMAX CO.,LTD
Model
Luxen Enamel B65 E0
Published
2025-02-07
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
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241151000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241151000LUXEN 5GDentalmax Co., Ltd.2024-09-30EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809900540171PrimaryGS10
08809900579423Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809900540171088099005401718809900540171
08809900579423088099005794238809900579423

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.

Regulatory Flags#

DUNS number
688528450
Device count
4
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809900540003LUXEN 5GLuxen Zr 4019 S12025-02-07
08809900540010LUXEN 5GLuxen Zr 4019 S22025-02-07
08809900540027LUXEN 5GLuxen Zr 4019 S32025-02-07
08809900540034LUXEN 5GLuxen Zr 5519 S12025-02-07
08809900540041LUXEN 5GLuxen Zr 5519 S22025-02-07
08809900540058LUXEN 5GLuxen Zr 5519 S32025-02-07
08809900540065LUXEN 5GLuxen Zr B65 S12025-02-07
08809900540072LUXEN 5GLuxen Zr B65 S22025-02-07
08809900540089LUXEN 5GLuxen Zr B65 S32025-02-07
08809900540096LUXEN 5GLuxen Enamel 4019 E02025-02-07
08809900540102LUXEN 5GLuxen Enamel 4019 E12025-02-07
08809900540119LUXEN 5GLuxen Enamel 4019 E22025-02-07
08809900540126LUXEN 5GLuxen Enamel 4019 E32025-02-07
08809900540133LUXEN 5GLuxen Enamel 5519 E02025-02-07
08809900540140LUXEN 5GLuxen Enamel 5519 E12025-02-07
08809900540157LUXEN 5GLuxen Enamel 5519 E22025-02-07
08809900540164LUXEN 5GLuxen Enamel 5519 E32025-02-07
08809900540188LUXEN 5GLuxen Enamel B65 E12025-02-07
08809900540195LUXEN 5GLuxen Enamel B65 E22025-02-07
08809900540201LUXEN 5GLuxen Enamel B65 E32025-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800121750769Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750776Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750806Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750837Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750844Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750875Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750882Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750899Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751117Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751124Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751131Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751148Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751193Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751209Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751254Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751261Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751278Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751285Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751339Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751346Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751353Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751360Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751377Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751384Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751803Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751810Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751827Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751834Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751889Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751896Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27