FDA.reportPublic FDA data

priti®multidisc ZrO2

Primary DI
04251366901005
Brand
priti®multidisc ZrO2
Company
Pritidenta GmbH
Model
13107-D985-14D2HT
Published
2017-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K161025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161025000priti multidisc ZrO2 High TranslucentPritidenta GmbH2017-02-03EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251366901005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251366901005042513669010054251366901005

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341632902
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251366923199SIN Zirconia SZMPW00252025-05-19
04251366923205SIN Zirconia SZMPOM1252025-05-19
04251366923212SIN Zirconia SZMPOM2252025-05-19
04251366923229SIN Zirconia SZMPOM3252025-05-19
04251366923236SIN Zirconia SZMPA10252025-05-19
04251366923243SIN Zirconia SZMPA20252025-05-19
04251366923250SIN Zirconia SZMPA30252025-05-19
04251366923267SIN Zirconia SZMPA35252025-05-19
04251366923274SIN Zirconia SZMPA40252025-05-19
04251366923281SIN Zirconia SZMPB10252025-05-19
04251366923298SIN Zirconia SZMPB20252025-05-19
04251366923304SIN Zirconia SZMPB30252025-05-19
04251366923311SIN Zirconia SZMPB40252025-05-19
04251366923328SIN Zirconia SZMPC10252025-05-19
04251366923335SIN Zirconia SZMPC20252025-05-19
04251366923342SIN Zirconia SZMPC30252025-05-19
04251366923359SIN Zirconia SZMPC40252025-05-19
04251366923366SIN Zirconia SZMPD20252025-05-19
04251366923373SIN Zirconia SZMPD30252025-05-19
04251366923380SIN Zirconia SZMPD40252025-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942629805069Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805298Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805526Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805755Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805984Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805090Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805229Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805236Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805243Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805328Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805458Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805465Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805472Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805557Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805571Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805687Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805694Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805700Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805915Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805922Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805939Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805946Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806011Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806141Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806158Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806165Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806172Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806264Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806387Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806394Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21