PRE-MADE REP. POST FOR PRAMA L-MD.-340-8

GUDID D7701827053

PRE-MADE REP. POST FOR PRAMA IMPLANT, D. 3.40 H.8 MM

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7701827053
• NIH Device Record Key: 6a293b1a-8e8b-48e3-940f-936ac5cd6234
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRE-MADE REP. POST FOR PRAMA
• Version Model Number: L-MD.-340-8
• Catalog Number: L-MD.-340-8
• 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
• 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	D7701827053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180365

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[D7701827053]

Moist Heat or Steam Sterilization

[D7701827053]

Moist Heat or Steam Sterilization

[D7701827053]

Moist Heat or Steam Sterilization

[D7701827053]

Moist Heat or Steam Sterilization

[D7701827053]

Moist Heat or Steam Sterilization

[D7701827053]

Moist Heat or Steam Sterilization

[D7701827053]

Moist Heat or Steam Sterilization

[D7701827053]

Moist Heat or Steam Sterilization

[D7701827053]

Moist Heat or Steam Sterilization

[D7701827053]

Moist Heat or Steam Sterilization

[D7701827053]

Moist Heat or Steam Sterilization

[D7701827053]

Moist Heat or Steam Sterilization

[D7701827053]

Moist Heat or Steam Sterilization

[D7701827053]

Moist Heat or Steam Sterilization

[D7701827053]

Moist Heat or Steam Sterilization

[D7701827053]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-02
• Device Publish Date: 2022-02-22

On-Brand Devices [PRE-MADE REP. POST FOR PRAMA]

• D7701284593: PRE-MADE REP. POST FOR PRAMA IMPLANT, D. 3.40 H.8 MM
• D7701284583: PRE-MADE REP. POST FOR PRAMA IMPLANT, D. 3.40 H.6 MM
• D7701422403: PRE-MADE REP. POST FOR PRAMA ANGLED PROSTHESIS D.3.40 H.6MM
• D7701591763: PRE-MADE REP. POST FOR PRAMA ANGLED PROSTHESIS D.3.40 H.10MM
• D7701827063: PRE-MADE REP. POST FOR PRAMA ANGLED PROSTHESIS D.3.40 H.10MM
• D7701827053: PRE-MADE REP. POST FOR PRAMA IMPLANT, D. 3.40 H.8 MM
• D7701827043: PRE-MADE REP. POST FOR PRAMA IMPLANT, D. 3.40 H.6 MM
• D7701524773: PRE-MADE REP. POST FOR PRAMA ANGLED PROSTHESIS D.3.40 H.6MM