PRAMA RF WHITE IMPLANT ZIRTI LSW-ZT-500SL-100

GUDID D7701513163

PRAMA RF WHITE IMPLANT ZIRTI WIDE THR. D5.00 H10MM

SWEDEN & MARTINA SPA

Screw endosteal dental implant, two-piece

• Primary Device ID: D7701513163
• NIH Device Record Key: fd4cc551-ba3e-44f4-9a19-1a8c9f65da5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRAMA RF WHITE IMPLANT ZIRTI
• Version Model Number: LSW-ZT-500SL-100
• Catalog Number: LSW-ZT-500SL-100
• 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
• 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	D7701513163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180365

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: 2021-04-20
• Device Publish Date: 2021-04-12

On-Brand Devices [PRAMA RF WHITE IMPLANT ZIRTI]

• D7701340713: PRAMA RF WHITE IMPLANT ZIRTI D. 5.00 H. 15 MM
• D7701340703: PRAMA RF WHITE IMPLANT ZIRTI D. 5.00 H. 13 MM
• D7701340693: PRAMA RF WHITE IMPLANT ZIRTI D. 5.00 H. 11.5 MM
• D7701340683: PRAMA RF WHITE IMPLANT ZIRTI D. 5.00 H. 10 MM
• D7701340673: PRAMA RF WHITE IMPLANT ZIRTI D. 5.00 H. 8.5 MM
• D7701340653: PRAMA RF WHITE IMPLANT ZIRTI D. 4.25 H. 15 MM
• D7701340643: PRAMA RF WHITE IMPLANT ZIRTI D. 4.25 H. 13 MM
• D7701340633: PRAMA RF WHITE IMPLANT ZIRTI D. 4.25 H. 11.5 MM
• D7701340623: PRAMA RF WHITE IMPLANT ZIRTI D. 4.25 H. 10 MM
• D7701340613: PRAMA RF WHITE IMPLANT ZIRTI D. 4.25 H. 8.5 MM
• D7701340593: PRAMA RF WHITE IMPLANT ZIRTI D. 3.80 H. 15 MM
• D7701340583: PRAMA RF WHITE IMPLANT ZIRTI D. 3.80 H. 13 MM
• D7701340573: PRAMA RF WHITE IMPLANT ZIRTI D. 3.80 H. 11.5 MM
• D7701340563: PRAMA RF WHITE IMPLANT ZIRTI D.3.80 H.10 MM
• D7701340553: PRAMA RF WHITE IMPLANT ZIRTI D. 3.80 H. 8.5 MM
• D7701513193: PRAMA RF WHITE IMPLANT ZIRTI WIDE THR.D5.00 H15MM
• D7701513183: PRAMA RF WHITE IMPLANT ZIRTI WIDE THR.D5.00 H13MM
• D7701513173: PRAMA RF WHITE IMPLANT ZIRTI WIDE THR.D5.00 H11.5MM
• D7701513163: PRAMA RF WHITE IMPLANT ZIRTI WIDE THR. D5.00 H10MM
• D7701513153: PRAMA RF WHITE IMPLANT ZIRTI WIDE THR. D5.00 H8.5MM
• D7701513143: PRAMA RF WHITE IMPLANT ZIRTI WIDE THR. D4.25 H15MM
• D7701513133: PRAMA RF WHITE IMPLANT ZIRTI WIDE THR. D4.25 H13MM
• D7701513123: PRAMA RF WHITE IMPLANT ZIRTI WIDE THR. D4.25 H11.5MM
• D7701513113: PRAMA RF WHITE IMPLANT ZIRTI WIDE THR. D4.25 H10MM
• D7701513103: PRAMA RF WHITE IMPLANT ZIRTI WIDE THR. D4.25 H8.5MM
• D7701513093: PRAMA RF WHITE IMPLANT ZIRTI WIDE THR. D3.80 H15MM
• D7701513083: PRAMA RF WHITE IMPLANT ZIRTI WIDE THR. D3.80 H13MM
• D7701513073: PRAMA RF WHITE IMPLANT ZIRTI WIDE THR.D3.80 H11.5MM
• D7701513063: PRAMA RF WHITE IMPLANT ZIRTI WIDE THR. D3.80 H10MM
• D7701513053: PRAMA RF WHITE IMPLANT ZIRTI WIDE THR. D3.80 H8.5MM
• D7701340663: PRAMA RF WHITE IMPLANT ZIRTI D. 5.00 H. 6 MM
• D7701340603: PRAMA RF WHITE IMPLANT ZIRTI D. 4.25 H. 6 MM