FDA.reportPublic FDA data

XTCERA

Primary DI
06973605092371
Brand
XTCERA
Company
DONGGUAN XIANGTONG CO.,LTD
Model
A3
Device description
30ml
Published
2022-09-15
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
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
06973605092371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973605092371069736050923716973605092371

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.

Regulatory Flags#

DUNS number
544441227
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973605092357XTCERAA12022-09-15
06973605092364XTCERAA22022-09-15
06973605092388XTCERAA3.52022-09-15
06973605092395XTCERAA42022-09-15
06973605092401XTCERAB12022-09-15
06973605092418XTCERAB22022-09-15
06973605092425XTCERAB32022-09-15
06973605092432XTCERAB42022-09-15
06973605092449XTCERAC12022-09-15
06973605092456XTCERAC22022-09-15
06973605092463XTCERAC32022-09-15
06973605092470XTCERAC42022-09-15
06973605092487XTCERAD22022-09-15
06973605092494XTCERAD32022-09-15
06973605092500XTCERAD42022-09-15
06973605092517XTCERA0M12022-09-15
06973605092524XTCERA0M22022-09-15
06973605092531XTCERA0M32022-09-15
06972434094518XTCERAXT-E 98*102022-09-02
06972434094525XTCERAXT-E 98*122022-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942686762657Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762664Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762671Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762688Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762695Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762701Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762718Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762725Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762732Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762749Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762756Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762763Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762770Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762787Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762794Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762800Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762817Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762824Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762831Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762848Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762855Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762862Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762879Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762886Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762893Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762909Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762916Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762923Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762930Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762947Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29