FDA.reportPublic FDA data

LUXEN Smile

Primary DI
08800046909600
Brand
LUXEN Smile
Company
DENTALMAX CO.,LTD
Model
LUXEN Smile-22T-D95-MB4
Published
2019-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K171585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171585000LUXEN Zr, LUXEN SmileDentalmax Co., Ltd.2018-10-31EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800046909600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800046909600088000469096008800046909600

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
06942508892586ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06942508892593ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06976691250007ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06976691250014ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501003ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501010ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501027ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501034ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501041ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501058ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501065ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501072ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
07615208543582IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543599IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543674IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543681IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543698IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543704IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543711IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543728IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543735IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543858IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543865IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543872IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543889IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543896IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543902IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543919IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544039IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544046IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07