FDA.reportPublic FDA data

Dental Porcelain Powder

Primary DI
06977209717944
Brand
Dental Porcelain Powder
Company
Yilink (Tianjin) Biotechnology Co., Ltd
Model
POW
Published
2026-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242400000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242400000Dental porcelain powderYilink (Tianjin) Biotechnology Co., Ltd.2024-10-10EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977209717944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977209717944069772097179446977209717944

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
602190359
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977209717753Dental Zirconia Ceramic BlockAT2026-03-12
06977209717760Dental Zirconia Ceramic BlockHT2026-03-11
06977209717777Dental Zirconia Ceramic BlockSHT2026-03-11
06977209717784Dental Zirconia Ceramic BlockSHTP2026-03-11
06977209717791Dental Zirconia Ceramic BlockColor2026-03-11
06977209717807Dental Zirconia Ceramic BlockColor-AT2026-03-11
06977209717814Dental Zirconia Ceramic BlockColor-SHTC2026-03-11
06977209717821Dental Zirconia Ceramic BlockColor-SHTP2026-03-11
06977209717838Dental Zirconia Ceramic BlockMultilayer2026-03-11
06977209717845Dental Zirconia Ceramic BlockMultilayer-AT2026-03-11
06977209717852Dental Zirconia Ceramic BlockMultilayer-SHT2026-03-11
06977209717869Dental Zirconia Ceramic BlockMultilayer-SHTP2026-03-11
06977209717876Dental Zirconia Ceramic BlockMultilayer-3D2026-03-11
06977209717883Dental Zirconia Ceramic BlockMultilayer-3DPro2026-03-11
06977209717890Dental Zirconia Ceramic BlockMulti-mix2026-03-11
06977209717906Dental Glass-ceramic BlockHT2026-03-11
06977209717913Dental Glass-ceramic BlockMT2026-03-11
06977209717920Dental Glass-ceramic BlockLT2026-03-11
06977209717937Dental Porcelain PowderPAS2026-03-11
06977209717951Dental Porcelain PowderLIQ2026-03-11

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