FDA.reportPublic FDA data

SIN Zirconia

Primary DI
04251366923274
Brand
SIN Zirconia
Company
Pritidenta GmbH
Model
SZMPA4025
Published
2025-05-19
Public version status
New
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
K100250000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100250000XCERAMXceramusa2010-04-08EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251366923274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251366923274042513669232744251366923274

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
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
04251366923878SIN Zirconia SZMPA10302025-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942629805106Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805113Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805120Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805137Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805144Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805151Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805168Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805175Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805182Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805199Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805205Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805212Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805250Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629808985Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809005Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809012Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809029Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809036Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809043Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
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