FDA.reportPublic FDA data

YUCERA

Primary DI
06942053501407
Brand
YUCERA
Company
Shenzhen Yurucheng Dental Materials Co., Ltd.
Model
A3.5
Catalog number
ST 98×35mm
Published
2023-08-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Single use
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K214003000
K214005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K214003000Dental Zirconia Pre-shaded BlockShenzhen Yurucheng Dental Materials Co., Ltd.2022-02-18EIH
K214005000Zirconia Dental CeramicsShenzhen Yurucheng Dental Materials Co., Ltd.2022-02-18EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06942053501407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942053501407069420535014076942053501407

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

Contacts#

Phone, Email table
PhoneEmail
+8675528228526system@yucera.com

Regulatory Flags#

DUNS number
402519411
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

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
06942445516118YUCERAML-BL3-SHTSHT Cylinder(98×12)mm2025-10-30
06942445516125YUCERAML-BL3-SHTSHT Cylinder(98×14)mm2025-10-30
06942445516132YUCERAML-BL3-SHTSHT Cylinder(98×16)mm2025-10-30
06942445516149YUCERAML-BL3-SHTSHT Cylinder(98×18)mm2025-10-30
06942445516156YUCERAML-BL3-SHTSHT Cylinder(98×20)mm2025-10-30
06942445516163YUCERAML-BL3-SHTSHT Cylinder(98×22)mm2025-10-30
06942445516170YUCERAML-BL3-SHTSHT Cylinder(98×25)mm2025-10-30
06942445516187YUCERAML-BL3-SHTSHT Cylinder(98×30)mm2025-10-30
06942445516194YUCERAML-BL3-SHTSHT Cylinder(98×35)mm2025-10-30
06942445516200YUCERAML-BL3-SHTSHT Cylinder(95×10)mm2025-10-30
06942445516217YUCERAML-BL3-SHTSHT Cylinder(95×12)mm2025-10-30
06942445516224YUCERAML-BL3-SHTSHT Cylinder(95×14)mm2025-10-30
06942445516231YUCERAML-BL3-SHTSHT Cylinder(95×16)mm2025-10-30
06942445516248YUCERAML-BL3-SHTSHT Cylinder(95×18)mm2025-10-30
06942445516255YUCERAML-BL3-SHTSHT Cylinder(95×20)mm2025-10-30
06942445516262YUCERAML-BL3-SHTSHT Cylinder(95×22)mm2025-10-30
06942445516279YUCERAML-BL3-SHTSHT Cylinder(95×25)mm2025-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942445510888YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445510895YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511007YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511014YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511021YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511038YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511045YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511052YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511069YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511076YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511083YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511090YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511106YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511113YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511120YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511137YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511144YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511151YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511168YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511175YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511182YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511199YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511304YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511311YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511328YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511335YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511342YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511359YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511366YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22
06942445511373YUCERAShenzhen Yurucheng Dental Materials Co., Ltd.PKJ2025-10-22