FDA.reportPublic FDA data

Coloring Liquid

Primary DI
06942377252603
Brand
Coloring Liquid
Company
SHENZHEN XIANGTONG CO., LTD
Model
B4 60ml
Published
2025-06-13
Public version status
Update
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
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
06942377252603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942377252603069423772526036942377252603

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
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EDMC32613087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32623024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32623087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32633024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32633087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32643024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32643087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32653024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32653087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32663024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32663087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32673024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32673087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32683024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32683087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32693024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32693087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32703024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32703087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32713024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32713087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32713098180NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32723024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32723087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32723098180NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32733024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32733087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16