Vsmilehappyzir Dental Zirconia Blank &Dental Zirconia Pre-Shaded Blank

GUDID 06974668761549

Hunan Vsmile Biotechnology Co.,Ltd

Dental appliance fabrication material, combination-material

• Primary Device ID: 06974668761549
• NIH Device Record Key: de29027c-d643-4e0c-9952-9244a3713d3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vsmilehappyzir Dental Zirconia Blank &Dental Zirconia Pre-Shaded Blank
• Version Model Number: 3D-pro-ML
• Company DUNS: 553229067
• Company Name: Hunan Vsmile Biotechnology 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974668761549 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221242

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: 2024-01-02
• Device Publish Date: 2023-12-25

On-Brand Devices [Vsmilehappyzir Dental Zirconia Blank &Dental Zirconia Pre-Shaded Blank]

• 06974668761556: 3D-Prism-ML
• 06974668761549: 3D-pro-ML
• 06974668761532: UT-ML
• 06974668761525: UT-C
• 06974668761518: UT
• 06974668761501: SHT-ML
• 06974668761495: SHT-C
• 06974668761488: SHT
• 06974668761471: ST-ML
• 06974668761464: ST-C
• 06974668761457: ST
• 06974668761440: HT plus