FDA.reportPublic FDA data

X-cera Pre-Shaded Zirconia Blanks

Primary DI
06942377283829
Brand
X-cera Pre-Shaded Zirconia Blanks
Company
SHENZHEN XIANGTONG CO., LTD
Model
XT-E 95×25
Device description
COLOR: A1Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/CAM technology to produce all ceramic dental restorations as prescribed by a dentist. All blanks are processed through dental laboratories or by dental professionals
Published
2025-07-28
Public version status
New
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
K202673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202673000X-cera Pre-shaded Zirconia BlanksDongguan Xiangtong Co., Ltd.2020-12-10EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06942377283829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942377283829069423772838296942377283829

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

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Primary DI, Brand, Company table
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