OUTLINK2 IMPLANT ZIRTI E2-ZT-330-100

GUDID D77010645637

OUTLINK2 IMPLANT ZIRTI D.3.30 H.10 MM

SWEDEN & MARTINA SPA

Screw endosteal dental implant, two-piece

• Primary Device ID: D77010645637
• NIH Device Record Key: 40edfb2e-17a4-42c3-a932-0a6d4828f08d
• Commercial Distribution Discontinuation: 2015-10-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: OUTLINK2 IMPLANT ZIRTI
• Version Model Number: E2-ZT-330-100
• Catalog Number: E2-ZT-330-100
• 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	D77010645637 [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: 2015-10-13

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• D7701609403 - STOP FOR CONICAL DRILL: 2025-08-01 STOP FOR CONICAL DRILL D.2.00-D.2.50 - H.18MM
• D7701609413 - STOP FOR CONICAL DRILL: 2025-08-01 STOP FOR CONICAL DRILL D.2.00-D.2.50 - H.19MM
• D7701609433 - STOP FOR CONICAL DRILL: 2025-08-01 STOP FOR CONICAL DRILL D.2.00-D.2.50 - H.21MM
• D7701609443 - STOP FOR CONICAL DRILL: 2025-08-01 STOP FOR CONICAL DRILL D.2.00-D.2.50 - H.22MM
• D7701609463 - STOP FOR CONICAL DRILL: 2025-08-01 STOP FOR CONICAL DRILL D.2.00-D.2.50 - H.24MM