SHELTA IMPLANT ZIRTI WIDE SH-ZT-380SL-130

GUDID D7701044303

SHELTA IMPLANT ZIRTI WIDE THREAD D.3.80 H.13 MM

SWEDEN & MARTINA SPA

Screw endosteal dental implant, two-piece

• Primary Device ID: D7701044303
• NIH Device Record Key: 38d77fd4-7ddc-48ff-adb8-3acb585e29a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHELTA IMPLANT ZIRTI WIDE
• Version Model Number: SH-ZT-380SL-130
• Catalog Number: SH-ZT-380SL-130
• 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	D7701044303 [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: 2015-09-21

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• D7702474263 - T-CONNECT FOR SINGLE CROWN: 2024-10-17 T-CONNECT FOR SINGLE CROWN A/SH D. 3,30 H.6 MM, H.3 MM
• D7702474283 - T-CONNECT FOR IMPLANTS BRIDGES: 2024-10-17 T-CONNECT FOR IMPLANTS BRIDGES A/SH D. 3,30 H.6 MM, H.1 MM
• D7702474293 - T-CONNECT FOR IMPLANTS BRIDGES: 2024-10-17 T-CONNECT FOR IMPLANTS BRIDGES A/SH D. 3,30 H.6 MM, H.2 MM