FDA.reportPublic FDA data

LUXEN 5G

Primary DI
08809900562753
Brand
LUXEN 5G
Company
DENTALMAX CO.,LTD
Model
Luxen Enamel G D98 BL2 14T
Published
2024-12-30
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
08809900562753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809900562753088099005627538809900562753

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
688528450
Device count
1
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
08809900540171LUXEN 5GLuxen Enamel B65 E02025-02-07
08809900540188LUXEN 5GLuxen Enamel B65 E12025-02-07
08809900540195LUXEN 5GLuxen Enamel B65 E22025-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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EDMC32723098180NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32733024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32733087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16