FDA.reportPublic FDA data

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Primary DI
16975018580121
Brand
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Company
Zirdent New Material Co.,Ltd
Model
SHT
Published
2022-09-30
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
16975018580121PackageGS140In Commercial Distribution
06975018580124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697501858012116975018580121
06975018580124069750185801246975018580124

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
true
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
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
16975018580107Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankUT-C2022-01-07
16975018580114Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankUT-ML2022-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J011250301010ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-09-25
J011250306010ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-09-25
J011254012040ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-09-25
J011254014040ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-09-25
J017BLSKCV20VITA LUMEX® ACVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-09-24
J017BLSKV20VITA LUMEX® ACVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-09-24
J017BLSTKCV20VITA LUMEX® ACVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-09-24
J017BV13BK12CV50VITA VM®13Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-09-24
J017BV13BK12V50VITA VM®13Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-09-24
J017BV13BKS12V50VITA VM®13Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-09-24
J017BV13GKV20VITA VM®13Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-09-24
J017BV13MKV20VITA VM®13Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-09-24
J017BV9GKV20VITA VM®9Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-09-24
J017BV9MKV20VITA VM®9Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-09-24
J017BVMKSETCV30VITA VMK Master®Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-09-24
J017LAMSKCV20VITA AMBRIA®Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-09-24
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
D800ZRTA106100Prettau 5 106H10ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106110Prettau 5 106H11ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106120Prettau 5 106H12ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106130Prettau 5 106H13ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106140Prettau 5 106H14ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106150Prettau 5 106H15ZIRKONZAHN SRLEIH2026-09-18