FDA.reportPublic FDA data

Dental Zirconia Ceramic Block

Primary DI
06977209717838
Brand
Dental Zirconia Ceramic Block
Company
Yilink (Tianjin) Biotechnology Co., Ltd
Model
Multilayer
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
K222520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222520000Zirconia BlockYilink (Tianjin) Biotechnology Co., Ltd.2022-11-14EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977209717838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977209717838069772097178386977209717838

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
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
06977209717944Dental Porcelain PowderPOW2026-03-11
06977209717951Dental Porcelain PowderLIQ2026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976581410009Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410016Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410023Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410030Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410047Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410054Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410061Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410078Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
EDDI963011DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963051DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963061DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963071DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963081DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963091DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963161DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963171DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963431DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963441DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963451DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963821DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963831DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963841DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963851DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963861DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963941DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963951DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963961DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963971DD cubeY® HLDental Direkt GmbHEIH2026-06-02
D800FMAA01030Colour Liquid A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28