SHELTA IMPLANT ZIRTI REGULAR SH-ZT-425-115

GUDID D7701044193

SHELTA IMPLANT ZIRTI REGULAR THREAD D.4.25 H.11.5 MM

SWEDEN & MARTINA SPA

Screw endosteal dental implant, two-piece

• Primary Device ID: D7701044193
• NIH Device Record Key: b19d70d3-c8ae-4417-aa0a-348576a78a6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHELTA IMPLANT ZIRTI REGULAR
• Version Model Number: SH-ZT-425-115
• Catalog Number: SH-ZT-425-115
• 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	D7701044193 [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

On-Brand Devices [SHELTA IMPLANT ZIRTI REGULAR]

• D7701232393: SHELTA IMPLANT ZIRTI REGULAR THREAD D.6.00 H.11.5 MM
• D7701044263: SHELTA IMPLANT ZIRTI REGULAR THREAD D.5.00 H.15 MM
• D7701044253: SHELTA IMPLANT ZIRTI REGULAR THREAD D.5.00 H.13 MM
• D7701044243: SHELTA IMPLANT ZIRTI REGULAR THREAD D.5.00 H.11.5 MM
• D7701044233: SHELTA IMPLANT ZIRTI REGULAR THREAD D.5.00 H.10 MM
• D7701044223: SHELTA IMPLANT ZIRTI REGULAR THREAD D.5.00 H.8.5 MM
• D7701044213: SHELTA IMPLANT ZIRTI REGULAR THREAD D.4.25 H.15 MM
• D7701044203: SHELTA IMPLANT ZIRTI REGULAR THREAD D.4.25 H.13 MM
• D7701044193: SHELTA IMPLANT ZIRTI REGULAR THREAD D.4.25 H.11.5 MM
• D7701044183: SHELTA IMPLANT ZIRTI REGULAR THREAD D.4.25 H.10 MM
• D7701044173: SHELTA IMPLANT ZIRTI REGULAR THREAD D.4.25 H.8.5 MM
• D7701044163: SHELTA IMPLANT ZIRTI REGULAR THREAD D.3.80 H.15 MM
• D7701044153: SHELTA IMPLANT ZIRTI REGULAR THREAD D.3.80 H.13 MM
• D7701044143: SHELTA IMPLANT ZIRTI REGULAR THREAD D.3.80 H.11.5 MM
• D7701044133: SHELTA IMPLANT ZIRTI REGULAR THREAD D.3.80 H.10 MM
• D7701044123: SHELTA IMPLANT ZIRTI REGULAR THREAD D.3.80 H.8.5 MM