FDA.reportPublic FDA data

CERABIEN™ MiLai

Primary DI
EKUR1091030KA0
Brand
CERABIEN™ MiLai
Company
KURARAY NORITAKE DENTAL INC.
Model
109-1030KA
Device description
Build/Paint Paste Advanced KIT
Published
2025-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K250673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250673000CERABIEN MiLaiKuraray Noritake Dental, Inc.2025-05-29EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKUR1091030KA0PrimaryHIBCC0

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
697119498
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EKUR1259852KA0KATANA™ Zirconia125-9852KA2026-03-01
EKUR1259863KA0KATANA™ Zirconia125-9863KA2026-03-01
EKUR1259874KA0KATANA™ Zirconia125-9874KA2026-03-01
EKUR1259882KA0KATANA™ Zirconia125-9882KA2026-03-01
EKUR1259893KA0KATANA™ Zirconia125-9893KA2026-03-01
EKUR1259904KA0KATANA™ Zirconia125-9904KA2026-03-01
EKUR1259915KA0KATANA™ Zirconia125-9915KA2026-03-01
EKUR004101KA1KATANA AVENCIA Block#4101-KA2019-04-30
EKUR004102KA1KATANA AVENCIA Block#4102-KA2019-04-30
EKUR004103KA1KATANA AVENCIA Block#4103-KA2019-04-30
EKUR004147KA1KATANA AVENCIA Block#4147-KA2019-04-30
EKUR004148KA1KATANA AVENCIA Block#4148-KA2019-04-30
EKUR004149KA1KATANA AVENCIA Block#4149-KA2019-04-30
EKUR1045931KA0CERABIEN™ ZR104-5931KA2026-01-12
EKUR1045941KA0CERABIEN™ ZR104-5941KA2026-01-12
EKUR1045951KA0CERABIEN™ ZR104-5951KA2026-01-12
EKUR1045961KA0CERABIEN™ ZR104-5961KA2026-01-12
EKUR1045971KA0CERABIEN™ ZR104-5971KA2026-01-12
EKUR1045982KA0CERABIEN™ ZR104-5982KA2026-01-12
EKUR1045992KA0CERABIEN™ ZR104-5992KA2026-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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EDMC32623024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
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EDMC32633087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32643024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32643087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32653024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32653087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32663024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
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EDMC32673024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
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EDMC32703024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32703087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32713024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32713087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32713098180NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32723024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32723087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32723098180NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32733024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32733087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16