Tizian Block 5.0

GUDID 04251366906420

Pritidenta GmbH

Dental appliance fabrication material, ceramic

• Primary Device ID: 04251366906420
• NIH Device Record Key: e086cfd9-1377-4fae-a6b7-c7f6decb2466
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tizian Block 5.0
• Version Model Number: 220961-TZ5Y-BL040
• Company DUNS: 341632902
• Company Name: Pritidenta GmbH
• 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: false
• 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	04251366906420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161025

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: 2020-07-20
• Device Publish Date: 2020-07-10

On-Brand Devices [Tizian Block 5.0]

• 04251366906420: 220961-TZ5Y-BL040
• 04251366906413: 220960-TZ5Y-AD040
• 04251366906406: 220959-TZ5Y-AL040