PROSTHETIC BOX FOR XA ABUTMENT PBOX-XA-ABU-ROT

GUDID D7701286113

PROSTHETIC BOX FOR XA ABUTMENT NON REPOSITIONABLE

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7701286113
• NIH Device Record Key: d6bbd594-c328-4674-b5fa-df2d85442f89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROSTHETIC BOX FOR XA ABUTMENT
• Version Model Number: PBOX-XA-ABU-ROT
• Catalog Number: PBOX-XA-ABU-ROT
• 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	D7701286113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162004

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[D7701286113]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-04-07

On-Brand Devices [PROSTHETIC BOX FOR XA ABUTMENT]

• D7701286113: PROSTHETIC BOX FOR XA ABUTMENT NON REPOSITIONABLE
• D7701285783: PROSTHETIC BOX FOR XA ABUTMENT REPOSITIONABLE