FDA.reportPublic FDA data

Glass Ceramic

Primary DI
06942340635457
Brand
Glass Ceramic
Company
SHENZHEN XIANGTONG CO., LTD
Model
CAD/CAM MO0
Published
2026-01-15
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
K252789000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252789000Glass CeramicShenzhen Xiangtong Co., Ltd.2025-12-08EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06942340635457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942340635457069423406354576942340635457

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
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
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