Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

GUDID 06975018580070

Zirdent New Material Co.,Ltd

Dental appliance fabrication material, combination-material

• Primary Device ID: 06975018580070
• NIH Device Record Key: 906d0d93-2921-459a-9aa6-eab36b389cd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
• Version Model Number: SHT-ML
• Company DUNS: 699451090
• Company Name: Zirdent New Material 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975018580070 [Primary]
GS1	16975018580077 [Package]; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212259

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: 2022-01-17
• Device Publish Date: 2022-01-07

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

• 16975018580114: UT-ML
• 16975018580107: UT-C
• 06975018580094: UT
• 06975018580087: 3D-pro-ML
• 06975018580070: SHT-ML
• 06975018580063: SHT-C
• 06975018580056: SHT-C
• 06975018580049: ST-ML
• 06975018580025: ST-C
• 06975018580018: ST
• 06975018580001: HT plus
• 16975018580121: SHT