PRAMA WHITE IMPLANT ZIRTI LAW-ZT-425-085

GUDID D7701340443

PRAMA WHITE IMPLANT ZIRTI D. 4.25 H. 8.5 MM

SWEDEN & MARTINA SPA

Screw endosteal dental implant, two-piece

• Primary Device ID: D7701340443
• NIH Device Record Key: c314b202-b4a1-4a33-a279-fc8483a2c033
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRAMA WHITE IMPLANT ZIRTI
• Version Model Number: LAW-ZT-425-085
• Catalog Number: LAW-ZT-425-085
• Company DUNS: 433815198
• Company Name: SWEDEN & MARTINA SPA
• 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: true
• 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

Customer Support Contacts

• Phone: 844.862.7846
• Email: info.us@sweden-martina.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7701340443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180365

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-24
• Device Publish Date: 2019-07-16

On-Brand Devices [PRAMA WHITE IMPLANT ZIRTI]

• D7701340543: PRAMA WHITE IMPLANT ZIRTI D. 5.00 H. 15 MM
• D7701340533: PRAMA WHITE IMPLANT ZIRTI D. 5.00 H. 13 MM
• D7701340523: PRAMA WHITE IMPLANT ZIRTI D. 5.00 H. 11.5 MM
• D7701340513: PRAMA WHITE IMPLANT ZIRTI D. 5.00 H. 10 MM
• D7701340503: PRAMA WHITE IMPLANT ZIRTI D. 5.00 H. 8.5 MM
• D7701340483: PRAMA WHITE IMPLANT ZIRTI D. 4.25 H. 15 MM
• D7701340473: PRAMA WHITE IMPLANT ZIRTI D. 4.25 H. 13 MM
• D7701340463: PRAMA WHITE IMPLANT ZIRTI D. 4.25 H. 11.5 MM
• D7701340453: PRAMA WHITE IMPLANT ZIRTI D. 4.25 H. 10 MM
• D7701340443: PRAMA WHITE IMPLANT ZIRTI D. 4.25 H. 8.5 MM
• D7701340423: PRAMA WHITE IMPLANT ZIRTI D. 3.80 H. 15 MM
• D7701340413: PRAMA WHITE IMPLANT ZIRTI D. 3.80 H. 13 MM
• D7701340403: PRAMA WHITE IMPLANT ZIRTI D. 3.80 H. 11.5 MM
• D7701340393: PRAMA WHITE IMPLANT ZIRTI D.3.80 H.10 MM
• D7701340383: PRAMA WHITE IMPLANT ZIRTI D. 3.80 H. 8.5 MM
• D7701340493: PRAMA WHITE IMPLANT ZIRTI D. 5.00 H. 6 MM
• D7701340433: PRAMA WHITE IMPLANT ZIRTI D. 4.25 H. 6 MM
• D7701340373: PRAMA WHITE IMPLANT ZIRTI D. 3.80 H. 6 MM