FDA.reportPublic FDA data

LUXEN CL

Primary DI
08809900579140
Brand
LUXEN CL
Company
DENTALMAX CO.,LTD
Model
Luxen CL-CCV1 100ml
Published
2023-12-21
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
K212548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212548000LUXEN CL Dental LiquidDentalmax Co., Ltd.2021-12-06EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809900579140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809900579140088099005791408809900579140

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
06942629805069Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805298Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805526Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805755Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805984Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805090Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805229Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805236Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805243Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805328Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805458Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805465Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805472Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805557Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805571Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805687Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805694Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805700Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805915Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805922Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805939Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805946Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806011Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806141Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806158Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806165Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806172Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806264Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806387Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806394Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21