CAST.REP. POST WITH TITANIUM A-UCTR-425-EX

GUDID D7700830803

CAST.REP. POST WITH TITANIUM BASE, PRE-KOH D.4.25 MM

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7700830803
• NIH Device Record Key: 9f8e8f70-6921-43a9-9c4f-4375fd242f6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAST.REP. POST WITH TITANIUM
• Version Model Number: A-UCTR-425-EX
• Catalog Number: A-UCTR-425-EX
• 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	D7700830803 [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

[D7700830803]

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 [CAST.REP. POST WITH TITANIUM]

• D7701061123: CAST.REP. POST WITH TITANIUM BASE, PRE-KOH D.5,00 MM
• D7701061113: CAST.REP. POST WITH TITANIUM BASE, PRE-KOH D.3.30 MM
• D7700830803: CAST.REP. POST WITH TITANIUM BASE, PRE-KOH D.4.25 MM
• D7700830773: CAST.REP. POST WITH TITANIUM BASE, PRE-KOH D.3.80 MM