FDA.reportPublic FDA data

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Primary DI
16977667920068
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
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
620039147
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
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
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
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
EYET38800000K2 MyStains Structure SetYeti Dentalprodukte GmbHEIH2026-05-20
EYET388000010K2 MyStains Structure SetYeti Dentalprodukte GmbHEIH2026-05-20
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