PREMIUM ONE IMPLANT ZIRTI AS-ZT-425-085

GUDID D7701304633

PREMIUM ONE IMPLANT ZIRTI D.4.25 H.8.5 MM

SWEDEN & MARTINA SPA

Screw endosteal dental implant, two-piece

• Primary Device ID: D7701304633
• NIH Device Record Key: ce32ce1e-768c-45bf-91d3-a97016412bc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREMIUM ONE IMPLANT ZIRTI
• Version Model Number: AS-ZT-425-085
• Catalog Number: AS-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	D7701304633 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172560

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: 2018-02-15

On-Brand Devices [PREMIUM ONE IMPLANT ZIRTI]

• D7701304813: PREMIUM ONE IMPLANT ZIRTI D.5.00 H.15 MM
• D7701304803: PREMIUM ONE IMPLANT ZIRTI D.5.00 H.13 MM
• D7701304793: PREMIUM ONE IMPLANT ZIRTI D.5.00 H.11.5 MM
• D7701304783: PREMIUM ONE IMPLANT ZIRTI D.5.00 H.10 MM
• D7701304773: PREMIUM ONE IMPLANT ZIRTI D.5.00 H.8.5 MM
• D7701304763: PREMIUM ONE IMPLANT ZIRTI D.5.00 H.7 MM
• D7701304683: PREMIUM ONE IMPLANT ZIRTI D.4.25 H.18 MM
• D7701304673: PREMIUM ONE IMPLANT ZIRTI D.4.25 H.15 MM
• D7701304663: PREMIUM ONE IMPLANT ZIRTI D.4.25 H.13 MM
• D7701304653: PREMIUM ONE IMPLANT ZIRTI D.4.25 H.11.5 MM
• D7701304643: PREMIUM ONE IMPLANT ZIRTI D.4.25 H.10 MM
• D7701304633: PREMIUM ONE IMPLANT ZIRTI D.4.25 H.8.5 MM
• D7701304623: PREMIUM ONE IMPLANT ZIRTI D.4.25 H.7 MM