OPEN TRAY TRANSFER FOR PRE-KOH A-TRA-425

GUDID D7700884833

OPEN TRAY TRANSFER FOR PRE-KOH STRAIGHT PROF., D.4.25 MM

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7700884833
• NIH Device Record Key: d4f0acec-3f5c-4e78-aef8-f6b8cac4b621
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPEN TRAY TRANSFER FOR PRE-KOH
• Version Model Number: A-TRA-425
• Catalog Number: A-TRA-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	D7700884833 [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

[D7700884833]

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: 2015-09-23

On-Brand Devices [OPEN TRAY TRANSFER FOR PRE-KOH]

• D7700884843: OPEN TRAY TRANSFER FOR PRE-KOH STRAIGHT PROF., D.5.00 MM
• D7700884833: OPEN TRAY TRANSFER FOR PRE-KOH STRAIGHT PROF., D.4.25 MM
• D7700755573: OPEN TRAY TRANSFER FOR PRE-KOH STRAIGHT PROF., D.3.80 MM