KOHNO ONE IMPLANT ZIRTI KS-ZT-425-115

GUDID D7701304893

KOHNO ONE IMPLANT ZIRTI ZT D.4.25 H.11.5 MM

SWEDEN & MARTINA SPA

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: D7701304893
• NIH Device Record Key: cac6655b-af3d-4810-9e97-021e61b5b851
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOHNO ONE IMPLANT ZIRTI
• Version Model Number: KS-ZT-425-115
• Catalog Number: KS-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
• Phone: 844.862.7846
• Email: info.us@sweden-martina.com
• Phone: 844.862.7846
• Email: info.us@sweden-martina.com
• Phone: 844.862.7846
• Email: info.us@sweden-martina.com
• Phone: 844.862.7846
• Email: info.us@sweden-martina.com
• Phone: 844.862.7846
• Email: info.us@sweden-martina.com
• Phone: 844.862.7846
• Email: info.us@sweden-martina.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7701304893 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-07
• Device Publish Date: 2022-06-29

On-Brand Devices [KOHNO ONE IMPLANT ZIRTI]

• D7701304953: KOHNO ONE IMPLANT ZIRTI ZT D.5.00 H.13 MM
• D7701304943: KOHNO ONE IMPLANT ZIRTI ZT D.5.00 H.11.5 MM
• D7701304933: KOHNO ONE IMPLANT ZIRTI ZT D.5.00 H.10 MM
• D7701304923: KOHNO ONE IMPLANT ZIRTI ZT D.4.25 H.18 MM
• D7701304913: KOHNO ONE IMPLANT ZIRTI ZT D.4.25 H.15 MM
• D7701304903: KOHNO ONE IMPLANT ZIRTI ZT D.4.25 H.13 MM
• D7701304893: KOHNO ONE IMPLANT ZIRTI ZT D.4.25 H.11.5 MM
• D7701304883: KOHNO ONE IMPLANT ZIRTI ZT D.4.25 H.10 MM