ANALOGUE FOR PLAIN ABUTMENT A-PLAIN-ANA-425

GUDID D770123070

ANALOGUE FOR PLAIN ABUTMENT D. 4.25 MM

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D770123070
• NIH Device Record Key: 275f155e-5c47-45a1-bb31-434f4237f1e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANALOGUE FOR PLAIN ABUTMENT
• Version Model Number: A-PLAIN-ANA-425
• Catalog Number: A-PLAIN-ANA-425
• 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	D770123070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142242

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[D770123070]

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: 2016-05-05

On-Brand Devices [ANALOGUE FOR PLAIN ABUTMENT]

• D770123071: ANALOGUE FOR PLAIN ABUTMENT D. 5.00 MM
• D770123070: ANALOGUE FOR PLAIN ABUTMENT D. 4.25 MM
• D770123069: ANALOGUE FOR PLAIN ABUTMENT D. 3.80 MM
• D770123068: ANALOGUE FOR PLAIN ABUTMENT D. 3.30 MM
• D7701029853: ANALOGUE FOR PLAIN ABUTMENT