FDA.reportPublic FDA data

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Primary DI
06977667920061
Brand
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Company
ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD
Model
ZD-SHT-C
Published
2024-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240672000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240672000Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)Zhejiang Zahndent Biotechnology Co., Ltd.2024-06-07EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16977667920068PackageGS150In Commercial Distribution
06977667920061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697766792006816977667920068
06977667920061069776679200616977667920061

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, combination-materialA dental material made of a combination of metal, ceramic, and/or synthetic polymer [e.g., polyethylene (PE)] 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.

Regulatory Flags#

DUNS number
620039147
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977667920016Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-HT-PLUS2024-07-27
06977667920023Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-ST2024-07-27
06977667920030Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-SHT2024-07-27
06977667920047Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-HT-C2024-07-27
06977667920054Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-ST-C2024-07-27
06977667920078Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-UT-C2024-07-27
06977667920085Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-ST-ML2024-07-27
06977667920092Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-SHT-ML2024-07-27
06977667920108Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-UT-ML2024-07-27
06977667920115Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-3D-Pro-ML2024-07-27
06977667920122Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-4D-Pro-ML2024-07-27
16977667920013Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-HT-PLUS2024-07-27
16977667920020Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-ST2024-07-27
16977667920037Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-SHT2024-07-27
16977667920044Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-HT-C2024-07-27
16977667920051Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-ST-C2024-07-27
16977667920068Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-SHT-C2024-07-27
16977667920075Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-UT-C2024-07-27
16977667920082Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-ST-ML2024-07-27
16977667920099Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-SHT-ML2024-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942629809364Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-10-08
06942629809548Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-10-08
06942629809739Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-10-08
06942629809814Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-10-08
06942629809821Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-10-08
008600015381992:34 MONOAMSUSA LLCEIH2026-10-07
J011250301010ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-09-25
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D800ZRTA09110Prettau 5 98H14 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09210Prettau 5 98H18 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09310Prettau 5 98H20 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09410Prettau 5 98H12 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09510Prettau 5 98H22 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09620Prettau 5 98H16 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09710Prettau 5 98H25 with stepZIRKONZAHN SRLEIH2026-09-18