Tizian Blank 5.0

GUDID 04251366906239

Pritidenta GmbH

Dental appliance fabrication material, ceramic

• Primary Device ID: 04251366906239
• NIH Device Record Key: 3ec694d3-407e-47a6-a8c3-ded808023e92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tizian Blank 5.0
• Version Model Number: 220940-TZ4Y-CL014
• 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	04251366906239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100250

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: 2020-07-06
• Device Publish Date: 2020-06-26

On-Brand Devices [Tizian Blank 5.0]

• 04251366906390: 220958-TZ4Y-W0025
• 04251366906383: 220957-TZ4Y-W0020
• 04251366906376: 220956-TZ4Y-W0018
• 04251366906369: 220955-TZ4Y-W0016
• 04251366906352: 220954-TZ4Y-W0014
• 04251366906345: 220951-TZ4Y-PB025
• 04251366906338: 220950-TZ4Y-PB020
• 04251366906321: 220949-TZ4Y-PB018
• 04251366906314: 220948-TZ4Y-PB014
• 04251366906307: 220947-TZ4Y-DL025
• 04251366906291: 220946-TZ4Y-DL020
• 04251366906284: 220945-TZ4Y-DL018
• 04251366906277: 220944-TZ4Y-DL014
• 04251366906260: 220943-TZ4Y-CL025
• 04251366906253: 220942-TZ4Y-CL020
• 04251366906246: 220941-TZ4Y-CL018
• 04251366906239: 220940-TZ4Y-CL014
• 04251366906222: 220939-TZ4Y-CD025
• 04251366906215: 220938-TZ4Y-CD020
• 04251366906208: 220937-TZ4Y-CD018
• 04251366906192: 220936-TZ4Y-CD014
• 04251366906185: 220935-TZ4Y-BL025
• 04251366906178: 220934-TZ4Y-BL020
• 04251366906161: 220933-TZ4Y-BL018
• 04251366906154: 220932-TZ4Y-BL014
• 04251366906147: 220931-TZ4Y-BD025
• 04251366906130: 220930-TZ4Y-BD020
• 04251366906123: 220929-TZ4Y-BD018
• 04251366906116: 220928-TZ4Y-BD014
• 04251366906109: 220927-TZ4Y-AL025
• 04251366906093: 220926-TZ4Y-AL020
• 04251366906086: 220925-TZ4Y-AL018
• 04251366906079: 220924-TZ4Y-AL014
• 04251366906062: 220923-TZ4Y-AD025
• 04251366906055: 220922-TZ4Y-AD020
• 04251366906048: 220921-TZ4Y-AD018
• 04251366906031: 220920-TZ4Y-AD014