FDA.reportPublic FDA data

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Primary DI
16977667920037
Brand
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Company
ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD
Model
ZD-SHT
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
16977667920037PackageGS150In Commercial Distribution
06977667920030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697766792003716977667920037
06977667920030069776679200306977667920030

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
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
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06942629809814Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-10-08
06942629809821Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-10-08
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D800ZRTA09010Prettau 5 98H10ZIRKONZAHN SRLEIH2026-09-18
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