OPEN TRAY TRANSFER A-PLAIN-TRA-380

GUDID D770123077

OPEN TRAY TRANSFER FOR PLAIN ABUTMENT D.3.80 MM

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D770123077
• NIH Device Record Key: 8bc604b7-d60d-400c-a13c-7d71d34704c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPEN TRAY TRANSFER
• Version Model Number: A-PLAIN-TRA-380
• Catalog Number: A-PLAIN-TRA-380
• 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	D770123077 [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

[D770123077]

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 [OPEN TRAY TRANSFER]

• D770123079: OPEN TRAY TRANSFER FOR PLAIN ABUTMENT D.5.00 MM
• D770123078: OPEN TRAY TRANSFER FOR PLAIN ABUTMENT D.4.25 MM
• D770123077: OPEN TRAY TRANSFER FOR PLAIN ABUTMENT D.3.80 MM
• D770123076: OPEN TRAY TRANSFER FOR PLAIN ABUTMENT D.3.30 MM
• D7701029843: OPEN TRAY TRANSFERFOR PLAIN ABUTMENT
• D7701253813: OPEN TRAY TRANSFER ANAT PROF, D.5.00 MM EX.2.30
• D7701253803: OPEN TRAY TRANSFER STRAIGHT, D.5.00 MM EX.2.30
• D7701245603: OPEN TRAY TRANSFER ANAT PROF, D.4.25 MM EX.2.30
• D7701245593: OPEN TRAY TRANSFER STRAIGHT, D.4.25 MM EX.2.30