FDA.reportPublic FDA data

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Primary DI
06975018580025
Brand
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Company
Zirdent New Material Co.,Ltd
Model
ST-C
Published
2022-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K212259000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212259000Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankZirdent New Material Co., Ltd.2021-11-12EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16975018580022PackageGS140In Commercial Distribution
06975018580025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697501858002216975018580022
06975018580025069750185800256975018580025

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
699451090
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975018580124Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankSHT2022-09-30
16975018580121Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankSHT2022-09-30
06975018580100Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankUT-C2022-01-07
06975018580117Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankUT-ML2022-01-07
06975018580001Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankHT plus 2022-01-07
06975018580018Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankST2022-01-07
06975018580049Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankST-ML2022-01-07
06975018580056Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankSHT-C2022-01-07
06975018580063Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankSHT-C2022-01-07
06975018580070Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankSHT-ML2022-01-07
06975018580087Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank3D-pro-ML 2022-01-08
06975018580094Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankUT2022-01-07
16975018580107Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankUT-C2022-01-07
16975018580114Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankUT-ML2022-01-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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