FDA.reportPublic FDA data

Dental Zirconia Ceramic Block

Primary DI
06977209717852
Brand
Dental Zirconia Ceramic Block
Company
Yilink (Tianjin) Biotechnology Co., Ltd
Model
Multilayer-SHT
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
06977209717852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977209717852069772097178526977209717852

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
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
E235P08380VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08390VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08580VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08590VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08610VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08620VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08630VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08640VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08650VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08660VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08670VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08680VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08690VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08710VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08720VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08730VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
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