FDA.reportPublic FDA data

DE corematrix

Primary DI
06974208587431
Brand
DE corematrix
Company
De Corematrix Co., Ltd.
Model
CMC/CMW
Published
2026-04-29
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
K192262000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192262000Dental Zirconia BlocksDe Corematrix Co., Ltd.2020-05-29EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974208587431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974208587431069742085874316974208587431

GMDN Terms#

Term, Definition table
TermDefinition
Dental porcelain/ceramic restoration kitA collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device.

Regulatory Flags#

DUNS number
554479198
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974208587103DE corematrixCMC/CMW2026-04-29
06974208587110DE corematrixCMC/CMW2026-04-29
06974208587127DE corematrixCMC/CMW2026-04-29
06974208587134DE corematrixCMC/CMW2026-04-29
06974208587141DE corematrixCMC/CMW2026-04-29
06974208587158DE corematrixCMC/CMW2026-04-29
06974208587165DE corematrixCMC/CMW2026-04-29
06974208587172DE corematrixCMC/CMW2026-04-29
06974208587189DE corematrixCMC/CMW2026-04-29
06974208587196DE corematrixCMC/CMW2026-04-29
06974208587202DE corematrixCMC/CMW2026-04-29
06974208587219DE corematrixCMC/CMW2026-04-29
06974208587226DE corematrixCMC/CMW2026-04-29
06974208587233DE corematrixCMC/CMW2026-04-29
06974208587240DE corematrixCMC/CMW2026-04-29
06974208587257DE corematrixCMC/CMW2026-04-29
06974208587264DE corematrixCMC/CMW2026-04-29
06974208587271DE corematrixCMC/CMW2026-04-29
06974208587288DE corematrixCMC/CMW2026-04-29
06974208587295DE corematrixCMC/CMW2026-04-29

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