PRE-MADE ENG. XA POST SH-MD-F-380-2

GUDID D7701248443

PRE-MADE ENG. XA POST H 2 MM D.3.80 MM

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7701248443
• NIH Device Record Key: eb02a956-21aa-4687-9f31-16a03649fbea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRE-MADE ENG. XA POST
• Version Model Number: SH-MD-F-380-2
• Catalog Number: SH-MD-F-380-2
• 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	D7701248443 [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

[D7701248443]

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: 2016-12-07

On-Brand Devices [PRE-MADE ENG. XA POST]

• D7701248463: PRE-MADE ENG. XA POST H 2 MM D.4.25 MM
• D7701248453: PRE-MADE ENG. XA POST H 1 MM D.4.25 MM
• D7701248443: PRE-MADE ENG. XA POST H 2 MM D.3.80 MM
• D7701248433: PRE-MADE ENG. XA POST H 1 MM D.3.80 MM
• D7701248423: PRE-MADE ENG. XA POST H 2 MM D.3.30 MM
• D7701248413: PRE-MADE ENG. XA POST H 1 MM D.3.30 MM