FDA.reportPublic FDA data

Coloring Liquid

Primary DI
06942377252542
Brand
Coloring Liquid
Company
SHENZHEN XIANGTONG CO., LTD
Model
A3 60ml
Published
2025-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220017000Coloring LiquidDongguan Xiangtong Co., Ltd.2022-06-29EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06942377252542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942377252542069423772525426942377252542

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis dyeA colouring intended to be used to stain a dental prosthesis (e.g., crown, bridge) before insertion in the patient to achieve a colour to match existing dentition. It is a mixture of inorganic chemicals typically used during the prosthesis manufacturing process. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
547044326
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942377274162XT stain/glazeGlaze powder 4g2025-05-21
06942377274179XT stain/glazeGlaze powder 5g2025-05-21
06942377274186XT stain/glazeStain glaze 4g2025-05-21
06942377274193XT stain/glazeStain glaze 5g2025-05-21
06942377274209XT stain/glazeGlaze liquid 20ml2025-05-21
06942377274216XT stain/glazeGlaze liquid 30ml2025-05-21
06942377274223XT stain/glazeGlaze liquid 50ml2025-05-21
06942377274230XT stain/glazeGlaze spray 50g2025-05-21
06942340635723Glass CeramicHot press 0M12026-01-15
06942340635730Glass CeramicHot press 0M22026-01-15
06942340635747Glass CeramicHot press 0M32026-01-15
06942377273899Glass Ceramic18×15×13 0M12025-06-30
06942377273905Glass Ceramic18×15×13 0M22025-06-30
06942377273912Glass Ceramic18×15×13 0M32025-06-30
06942377273998Glass Ceramic40×15×15 B32025-06-30
06942377274124Glass Ceramic40×15×15 0M12025-06-30
06942377274131Glass Ceramic40×15×15 0M22025-06-30
06942377274148Glass Ceramic40×15×15 0M32025-06-30
06942377249573X-cera Zirconia BlanksXW 98×122025-06-30
06942377249580X-cera Zirconia BlanksXW 98×142025-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800121750769Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750776Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750806Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750837Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750844Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750875Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750882Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750899Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751117Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751124Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751131Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751148Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751193Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751209Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751254Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751261Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751278Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751285Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751339Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751346Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751353Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751360Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751377Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751384Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751803Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751810Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751827Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751834Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751889Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751896Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27