BALL ATTACHMENT IMPL. PRE/KOH A-AS-425-4

GUDID D7700636903

BALL ATTACHMENT IMPL. PRE/KOH D.4,25 H.4 MM

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7700636903
• NIH Device Record Key: a6259efb-2813-4bb6-aa5a-6e4b09d191b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BALL ATTACHMENT IMPL. PRE/KOH
• Version Model Number: A-AS-425-4
• Catalog Number: A-AS-425-4
• 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	D7700636903 [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

[D7700636903]

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 [BALL ATTACHMENT IMPL. PRE/KOH]

• D7700701143: BALL ATTACHMENT IMPL. PRE/KOH D.5,00 H.2 MM
• D7700636903: BALL ATTACHMENT IMPL. PRE/KOH D.4,25 H.4 MM
• D7700636893: BALL ATTACHMENT IMPL. PRE/KOH D.4,25 H.2 MM
• D7700636883: BALL ATTACHMENT IMPL. PRE/KOH D.4,25 H.1 MM
• D7700636873: BALL ATTACHMENT IMPL. PRE/KOH D.3,80 H.4 MM
• D7700636863: BALL ATTACHMENT IMPL. PRE/KOH D.3,80 H.2 MM
• D7700636853: BALL ATTACHMENT IMPL. PRE/KOH D.3,80 H.1 MM
• D7700636843: BALL ATTACHMENT IMPL. PRE/KOH D.3,30 H.4 MM
• D7700636833: BALL ATTACHMENT IMPL. PRE/KOH D.3,30 H.2 MM
• D7700636823: BALL ATTACHMENT IMPL. PRE/KOH D.3,30 H.1 MM