SHELTA IMPLANT ZIRTI WIDE SH-ZT-425SL-150

GUDID D7701044363

SHELTA IMPLANT ZIRTI WIDE THREAD D.4.25 H.15 MM

SWEDEN & MARTINA SPA

Screw endosteal dental implant, two-piece

• Primary Device ID: D7701044363
• NIH Device Record Key: 3e6b561b-ed7d-45e0-99b2-3e354629cb9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHELTA IMPLANT ZIRTI WIDE
• Version Model Number: SH-ZT-425SL-150
• Catalog Number: SH-ZT-425SL-150
• 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	D7701044363 [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 WIDE]

• D7701044413: SHELTA IMPLANT ZIRTI WIDE THREAD D.5.00 H.15 MM
• D7701044403: SHELTA IMPLANT ZIRTI WIDE THREAD D.5.00 H.13 MM
• D7701044393: SHELTA IMPLANT ZIRTI WIDE THREAD D.5.00 H.11.5 MM
• D7701044383: SHELTA IMPLANT ZIRTI WIDE THREAD D.5.00 H.10 MM
• D7701044373: SHELTA IMPLANT ZIRTI WIDE THREAD D.5.00 H.8.5 MM
• D7701044363: SHELTA IMPLANT ZIRTI WIDE THREAD D.4.25 H.15 MM
• D7701044353: SHELTA IMPLANT ZIRTI WIDE THREAD D.4.25 H.13 MM
• D7701044343: SHELTA IMPLANT ZIRTI WIDE THREAD D.4.25 H.11.5 MM
• D7701044333: SHELTA IMPLANT ZIRTI WIDE THREAD D.4.25 H.10 MM
• D7701044323: SHELTA IMPLANT ZIRTI WIDE THREAD D.4.25 H.8.5 MM
• D7701044313: SHELTA IMPLANT ZIRTI WIDE THREAD D.3.80 H.15 MM
• D7701044293: SHELTA IMPLANT ZIRTI WIDE THREAD D.3.80 H.11.5 MM
• D7701044283: SHELTA IMPLANT ZIRTI WIDE THREAD D.3.80 H.10 MM
• D7701044273: SHELTA IMPLANT ZIRTI WIDE THREAD D.3.80 H.8.5 MM