FDA.reportPublic FDA data

XTCERA

Primary DI
06972434099483
Brand
XTCERA
Company
DONGGUAN XIANGTONG CO.,LTD
Model
XW98*16
Device description
HT Pro
Published
2022-09-01
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
K153767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153767000X-cera Zirconia BlanksShenzhen Xiangtong Photoelectricity Technology Co., Ltd.2016-03-29EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972434099483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972434099483069724340994836972434099483

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods#

Method table
Method

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
06973605092371XTCERAA32022-09-15
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

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