X-cera Pre-Shaded Zirconia Blanks

GUDID 06942377277682

COLOR: BL2 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: 06942377277682
• NIH Device Record Key: 48b4bb78-91e2-419a-8f42-1859bd6f402d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-cera Pre-Shaded Zirconia Blanks
• Version Model Number: XT-E 98×16
• 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	06942377277682 [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

On-Brand Devices [X-cera Pre-Shaded Zirconia Blanks]

• 06942377249696: COLOR: B1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377249689: COLOR: A4 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377249672: COLOR: A3.5 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD
• 06942377249665: COLOR: A3 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377249658: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377249641: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377283898: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377283836: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377283829: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377283812: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377279587: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377279549: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377279532: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377279525: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377279518: COLOR: A1
• 06942377252375: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377252368: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377252214: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377252207: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377252054: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377252047: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377251897: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377251880: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377251736: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377251729: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377251583: COLOR: A3 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377251576: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377251569: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377251422: COLOR: A3 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377251415: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377251408: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377251262: COLOR: A3 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377251255: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377251248: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377251101: COLOR: A3 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377251095: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377251088: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377250937: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377250920: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377250777: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377250760: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377250616: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377250609: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377250456: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377250449: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377250302: COLOR: A3 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377250296: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377250289: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377250135: COLOR: A2 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C
• 06942377250128: COLOR: A1 Indications for Use: X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/C