XTCERA

GUDID 06972434095225

3D-C2

DONGGUAN XIANGTONG CO.,LTD

Dental appliance fabrication material, ceramic

• Primary Device ID: 06972434095225
• NIH Device Record Key: 5b5c429f-9532-4a01-8e7e-d6f9d0c65fa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XTCERA
• Version Model Number: XT-E 98*25
• Company DUNS: 544441227
• Company Name: DONGGUAN 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: true
• 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	06972434095225 [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: 2022-09-12
• Device Publish Date: 2022-09-02

On-Brand Devices [XTCERA]

• 06972434090268: SHT
• 06972434090251: SHT
• 06972434090244: SHT
• 06972434090237: SHT
• 06972434090220: SHT
• 06972434090213: SHT
• 06972434090206: SHT
• 06972434090169: HT
• 06972434090152: HT
• 06972434090145: HT
• 06972434090138: HT
• 06972434090121: HT
• 06972434090114: HT
• 06972434090190: SHT
• 06972434090183: HT
• 06972434090176: HT
• 06972434099520: HT Pro
• 06972434099513: HT Pro
• 06972434099506: HT Pro
• 06972434099490: HT Pro
• 06972434099483: HT Pro
• 06972434099476: HT Pro
• 06972434099469: HT Pro
• 06972434099452: HT Pro
• 06972434095577: 3D-D4
• 06972434095522: 3D-D3
• 06972434095409: 3D-D2
• 06972434095331: 3D-C4
• 06972434095218: 3D-C2
• 06972434095010: 3D-B4
• 06972434094976: 3D-B3
• 06972434094938: 3D-B3
• 06972434094921: 3D-B3
• 06972434094914: 3D-B3
• 06972434094761: 3D-B1
• 06972434094730: 3D-A4
• 06972434094716: 3D-A4
• 06972434094679: 3D-A4
• 06972434094556: 3D-A3
• 06972434094501: 3D-A2
• 06972434094495: 3D-A2
• 06972434094471: 3D-A2
• 06972434094464: 3D-A2
• 06972434094457: 3D-A2
• 06972434094440: 3D-A2
• 06972434094433: 3D-A2
• 06972434094426: 3D-A1
• 06972434094419: 3D-A1
• 06972434094402: 3D-A1
• 06972434094396: 3D-A1