GLOBAL IMPLANT ZIRTI U-ZT-380-085

GUDID D7700891693

GLOBAL IMPLANT ZIRTI D.3.80 H.8.5 MM

SWEDEN & MARTINA SPA

Screw endosteal dental implant, two-piece

• Primary Device ID: D7700891693
• NIH Device Record Key: b56487d5-c2a9-4b5d-9ce1-6693fd9defe5
• Commercial Distribution Discontinuation: 2017-01-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GLOBAL IMPLANT ZIRTI
• Version Model Number: U-ZT-380-085
• Catalog Number: U-ZT-380-085
• 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	D7700891693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142242

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-12

Devices Manufactured by SWEDEN & MARTINA SPA

• D7701447763 - HANDLE: 2025-07-01 HANDLE FLUSILIFT EVO
• D7702680153 - 17GR ANG. EST. PAD ABUT.: 2025-07-01 17GR ANG. EST. PAD ABUT. H3 MM, D.3.30 MM
• D7702680163 - 17GR ANG. EST. PAD ABUT.: 2025-07-01 17GR ANG. EST. PAD ABUT. H5 MM, D.3.30 MM
• D7702680173 - 30GR ANG. EST. PAD ABUT.: 2025-07-01 30GR ANG. EST. PAD ABUT. H3 MM, D.3.30 MM
• D7702680183 - 30GR ANG. EST. PAD ABUT.: 2025-07-01 30GR ANG. EST. PAD ABUT. H5 MM, D.3.30 MM
• D7702680213 - 17GR ANG. EST. PAD ABUT.: 2025-07-01 17GR ANG. EST. PAD ABUT. H3 MM, D.3.80 MM
• D7702680223 - 17GR ANG. EST. PAD ABUT.: 2025-07-01 17GR ANG. EST. PAD ABUT. H5 MM, D.3.80 MM
• D7702680233 - 30GR ANG. EST. PAD ABUT.: 2025-07-01 30GR ANG. EST. PAD ABUT. H3 MM, D.3.80 MM