FDA.reportPublic FDA data

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Primary DI
16975018580107
Brand
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Company
Zirdent New Material Co.,Ltd
Model
UT-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
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
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
16975018580107PackageGS140In Commercial Distribution
06975018580100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697501858010716975018580107
06975018580100069750185801006975018580100

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
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
false
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
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
06975018580025Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankST-C2022-01-07
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
16975018580114Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankUT-ML2022-01-07

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Primary DI, Brand, Company table
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