FDA.reportPublic FDA data

YUCERA

Primary DI
06942445508113
Brand
YUCERA
Company
Shenzhen Yurucheng Dental Materials Co., Ltd.
Model
OM2
Catalog number
ST Cylinder(95×12)mm
Published
2025-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PKJCrown And Bridge Material, Resin Based

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKJCrown And Bridge Material, Resin BasedUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06942053504927PreviousGS10
06942445508113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942053504927069420535049276942053504927
06942445508113069424455081136942445508113

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
402519411
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942445562702YUCERAML-B3-ST2026-01-07
06942445562719YUCERAML-C1-ST2026-01-07
06942445562726YUCERAML-C3-ST2026-01-07
06942445509295YUCERABL3ST Cylinder(98×35)mm2025-09-29
06942445509301YUCERABL3ST Cylinder(95×10)mm2025-09-29
06942445509318YUCERABL3ST Cylinder(95×12)mm2025-09-29
06942445509325YUCERABL3ST Cylinder(95×14)mm2025-09-29
06942445509332YUCERABL3ST Cylinder(95×16)mm2025-09-29
06942445509349YUCERABL3ST Cylinder(95×18)mm2025-09-29
06942445509356YUCERABL3ST Cylinder(95×20)mm2025-09-29
06942445509363YUCERABL3ST Cylinder(95×22)mm2025-09-29
06942445509370YUCERABL3ST Cylinder(95×25)mm2025-09-29
06942445509516YUCERABL4ST Cylinder(98×12)mm2025-09-29
06942445508458YUCERAOM3ST Cylinder(95×20)mm2025-09-26
06942445508465YUCERAOM3ST Cylinder(95×22)mm2025-09-26
06942445508472YUCERAOM3ST Cylinder(95×25)mm2025-09-26
06942445508601YUCERABL1ST Cylinder(98×10)mm2025-09-26
06942445508618YUCERABL1ST Cylinder(98×12)mm2025-09-26
06942445508625YUCERABL1ST Cylinder(98×14)mm2025-09-26
06942445508632YUCERABL1ST Cylinder(98×16)mm2025-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942445562702YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2026-01-07
06942445562719YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2026-01-07
06942445562726YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2026-01-07
06942445509295YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-29
06942445509301YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-29
06942445509318YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-29
06942445509325YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-29
06942445509332YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-29
06942445509349YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-29
06942445509356YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-29
06942445509363YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-29
06942445509370YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-29
06942445509516YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-29
06942445508977YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28
06942445508984YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28
06942445508991YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28
06942445509028YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28
06942445509035YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28
06942445509042YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28
06942445509059YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28
06942445509066YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28
06942445509073YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28
06942445509202YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28
06942445509219YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28
06942445509226YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28
06942445509233YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28
06942445509240YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28
06942445509257YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28
06942445509264YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28
06942445509288YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-09-28