FDA.report

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Primary DI
16977667920105
Brand
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Company
ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD
Model
ZD-UT-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
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EIHPowder, Porcelain

Product Code Classifications

CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions

SubmissionSupplement
K240672000

Premarket Details

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

IdentifierTypeAgencyPackage quantityStatus
16977667920105PackageGS150In Commercial Distribution
06977667920108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1697766792010516977667920105
06977667920108069776679201086977667920108

GMDN Terms

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

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 DIBrandModelCatalogPublished
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
16977667920112Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-3D-Pro-ML2024-07-27
16977667920129Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZD-4D-Pro-ML2024-07-27

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