FDA.reportPublic FDA data

Zrcoop

Primary DI
06975409640062
Brand
Zrcoop
Company
Hangzhou Thales Medtech Co., Ltd.
Model
Additive manufacturing of zirconia porcelain venee
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

Contact Domains#

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
06975409640062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975409640062069754096400626975409640062

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

Contacts#

Phone, Email table
PhoneEmail
+86057186066890contact@Thalesmedtech.com

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
06975409640079ZrcoopAdditive manufacturing of zirconia inlays2025-01-03
06975409641007ZrcoopAdditive manufacturing of zirconia porcelain crown2025-01-03
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
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00817724020104Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020111Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020128Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
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