FDA.reportPublic FDA data

Zrcoop

Primary DI
06975409641007
Brand
Zrcoop
Company
Hangzhou Thales Medtech Co., Ltd.
Model
Additive manufacturing of zirconia porcelain crown
Device description
Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structure of prostheses for partially edentulous patients in need of prosthetic oral reconstruction to restore chewing function and aesthetics. The Additive Manufacturing Zirconia Customized Restoration is a premanufactured prosthetic component and is indicated for use as restorations (Crown,Bridge,Veneer,Inlay) that will be cemented to a natural or artificial tooth abutment.
Published
2025-01-03
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
ELLTeeth, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2
ELLTeeth, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240586000Additive Manufacturing Zirconia Customized RestorationHangzhou Thales Medtech Co., Ltd.2024-10-03ELL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975409641007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975409641007069754096410076975409641007

GMDN Terms#

Term, Definition table
TermDefinition
Complete upper dentureA custom-made artificial replacement for all teeth in the upper jaw (maxilla) carried on a removable plate or frame which is supported by surrounding soft and hard tissues of the oral cavity. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)].

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
841846639
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975409640055ZrcoopAdditive manufacturing of zirconia porcelain crown2025-01-03
06975409640062ZrcoopAdditive manufacturing of zirconia porcelain venee2025-01-03
06975409640079ZrcoopAdditive manufacturing of zirconia inlays2025-01-03
06975409642004Cerawhiteporcelain-veneer2023-05-15
06975409643001Cerawhitecrown/bridge2023-05-15
06975409644008Cerawhiteporcelain-crown/bridge2023-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976581410009Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410016Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410023Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410030Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410047Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410054Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410061Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410078Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
EDDI963011DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963051DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963061DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963071DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963081DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963091DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963161DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963171DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963431DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963441DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963451DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963821DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963831DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963841DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963851DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963861DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963941DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963951DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963961DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963971DD cubeY® HLDental Direkt GmbHEIH2026-06-02
D800FMAA01030Colour Liquid A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28