FDA.reportPublic FDA data

ZIRento

Primary DI
D862Z16A11298ST0
Brand
ZIRento
Company
DISTRIBUDENT, LLC
Model
Z16A1-1298ST
Device description
ZIRento 16 A1 12mm 98mm Step
Published
2016-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K130924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130924000BRUXZIR SHADEDPrismatik Dentalcraft, Inc.2013-05-16EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D862Z16A11298ST0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height12Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080458846
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D862Z16A11298STSI0ZIRentoZ16A1-1298ST-SI2017-02-10
D862Z16A11598ST0ZIRentoZ16A1-1598ST2016-12-07
D862Z16A11598STSI0ZIRentoZ16A1-1598ST-SI2017-02-10
D862Z16A12098ST0ZIRentoZ16A1-2098ST2016-12-07
D862Z16A12098STSI0ZIRentoZ16A1-2098ST-SI2017-02-10
D862Z16A12598ST0ZIRentoZ16A1-2598ST2016-12-07
D862Z16A12598STSI0ZIRentoZ16A1-2598ST-SI2017-02-10
D862Z16A21298ST0ZIRentoZ16A2-1298ST2016-12-07
D862Z16A21298STSI0ZIRentoZ16A2-1298ST-SI2017-02-10
D862Z16A21598ST0ZIRentoZ16A2-1598ST2016-12-07
D862Z16A21598STSI0ZIRentoZ16A2-1598ST-SI2017-02-10
D862Z16A22098ST0ZIRentoZ16A2-2098ST2016-12-07
D862Z16A22098STSI0ZIRentoZ16A2-2098ST-SI2017-02-10
D862Z16A22598ST0ZIRentoZ16A2-2598ST2016-12-07
D862Z16A22598STSI0ZIRentoZ16A2-2598ST-SI2017-02-10
D862Z16A31298ST0ZIRentoZ16A3-1298S2016-12-07
D862Z16A31298STSI0ZIRentoZ16A3-1298ST-SI2017-02-10
D862Z16A31598ST0ZIRentoZ16A3-1598ST2016-12-07
D862Z16A31598STSI0ZIRentoZ16A3-1598ST-SI2017-02-10
D862Z16A32098ST0ZIRentoZ16A3-2098ST2016-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06942629809012Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
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06942629809036Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
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06942629809074Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809098Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809104Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809111Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809128Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809135Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629808732Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29
06942629808749Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29
06942629808756Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29
06942629808763Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29
06942629808770Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29