FDA.reportPublic FDA data

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Primary DI
06977667920122
Brand
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Company
ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD
Model
ZD-4D-Pro-ML
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
16977667920129PackageGS150In Commercial Distribution
06977667920122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697766792012916977667920129
06977667920122069776679201226977667920122

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
06977667920061Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-SHT-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
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
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EYET38800230K2 MyStains ST-S13, uni red, 2g.Yeti Dentalprodukte GmbHEIH2026-05-20
EYET38800240K2 MyStains ST-S14, uni gingiva, 2g.Yeti Dentalprodukte GmbHEIH2026-05-20
EYET38780110K2 Li-Press-Pellets (HT-Hoch Transluzent) B1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780120K2 Li-Press-Pellets (HT-Hoch Transluzent) B1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780210K2 Li-Press-Pellets (HT-Hoch Transluzent) C1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780310K2 Li-Press-Pellets (HT-Hoch Transluzent) BL1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780320K2 Li-Press-Pellets (HT-Hoch Transluzent) BL3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780330K2 Li-Press-Pellets (HT-Hoch Transluzent) BL2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780340K2 Li-Press-Pellets (HT-Hoch Transluzent) BL4, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781010K2 Li-Press-Pellets (LT-Low Transluzent) A1, 5X3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781020K2 Li-Press-Pellets (LT-Low Transluzent) A2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781030K2 Li-Press-Pellets (LT-Low Transluzent) A3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781110K2 Li-Press-Pellets (LT-Low Transluzent) B1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781120K2 Li-Press-Pellets (LT-Low Transluzent) B2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781210K2 Li-Press-Pellets (LT-Low Transluzent) C1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781310K2 Li-Press-Pellets (LT-Low Transluzent) BL1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781320K2 Li-Press-Pellets (LT-Low Transluzent) BL2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781330K2 Li-Press-Pellets (LT-Low Transluzent) BL3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781340K2 Li-Press-Pellets (LT-Low Transluzent) BL4, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38782010K2 Li-Press-Pellets (medium-opak) MO1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780010K2 Li Press-Pellets HT-A1Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38780020K2 Li Press-Pellets HT-A2Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38780030K2 Li-Press-Pellets (HT-Hoch Transluzent) A3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38801100K2 MyStains Structure Body dark, SM-B-D, 2g.Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38760020K2 Li-Mamelon, MM-HO (HONEY), 20g.Yeti Dentalprodukte GmbHEIH2026-05-05
EYET38626150K2-HF OPAQUE DENTIN, OD-D3, 50g.Yeti Dentalprodukte GmbHEIH2026-05-04
EYET38750060K2 Li-Clear, CL, 20g.Yeti Dentalprodukte GmbHEIH2026-05-04
EYET38760010K2 Li-Mamelon, MM-OR (ORANGE), 20g.Yeti Dentalprodukte GmbHEIH2026-05-04