XT-D 98×14

GUDID 06942377275787

COLOR: BL3 Indications 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

SHENZHEN XIANGTONG CO., LTD

Dental appliance fabrication material, ceramic

• Primary Device ID: 06942377275787
• NIH Device Record Key: 0a60ecd3-9a0e-4d03-8f84-1fcb7f5a8659
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XT-D 98×14
• Version Model Number: XT-D 98×14
• Company DUNS: 547044326
• Company Name: SHENZHEN XIANGTONG CO., LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942377275787 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202673

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-18
• Device Publish Date: 2025-08-10

Devices Manufactured by SHENZHEN XIANGTONG CO., LTD

• 06942377249887 - X-cera Pre-Shaded Zirconia Blanks: 2025-08-18 COLOR: B4 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/CAM technology to produce all cer
• 06942377249894 - X-cera Pre-Shaded Zirconia Blanks: 2025-08-18 COLOR: C1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/CAM technology to produce all cer
• 06942377249900 - X-cera Pre-Shaded Zirconia Blanks: 2025-08-18 COLOR: C2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/CAM technology to produce all cer
• 06942377249917 - X-cera Pre-Shaded Zirconia Blanks: 2025-08-18 COLOR: C3 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/CAM technology to produce all cer
• 06942377249924 - X-cera Pre-Shaded Zirconia Blanks: 2025-08-18 COLOR: C4 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/CAM technology to produce all cer
• 06942377249931 - X-cera Pre-Shaded Zirconia Blanks: 2025-08-18 COLOR: D2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/CAM technology to produce all cer
• 06942377249948 - X-cera Pre-Shaded Zirconia Blanks: 2025-08-18 COLOR: D3 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/CAM technology to produce all cer
• 06942377249955 - X-cera Pre-Shaded Zirconia Blanks: 2025-08-18 COLOR: D4 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/CAM technology to produce all cer