T CONNECT FOR SINGLE A-TCS-425L-C

GUDID D7701112163

T CONNECT FOR SINGLE -2 CROWN FOR A/K425 CONE LARGE

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7701112163
• NIH Device Record Key: e1802183-6a69-4d61-8a05-c9624a0b25ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T CONNECT FOR SINGLE
• Version Model Number: A-TCS-425L-C
• Catalog Number: A-TCS-425L-C
• 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	D7701112163 [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

[D7701112163]

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: 2016-08-25

On-Brand Devices [T CONNECT FOR SINGLE]

• D7701112173: T CONNECT FOR SINGLE -2 CROWN FOR A/K500 CONE LARGE
• D7701112163: T CONNECT FOR SINGLE -2 CROWN FOR A/K425 CONE LARGE
• D7701112143: T CONNECT FOR SINGLE -2 CROWN FOR A/K380 CONE SMALL
• D7701112133: T CONNECT FOR SINGLE -2 CROWN FOR A 330 CONE SMALL
• D7701452923: T CONNECT FOR SINGLE CROWN D.3.80, TMG.H.2.5 MM
• D7701452913: T CONNECT FOR SINGLE CROWN D.3.80, TMG.H.1.5 MM
• D7701452903: T CONNECT FOR SINGLE CROWN D.3.30, TMG.H.2.5 MM
• D7701452893: T CONNECT FOR SINGLE CROWN D.3.30, TMG.H.1.5 MM
• D7701377673: T CONNECT FOR SINGLE CROWN-2, DEEP 0.5 D.5.00 LARGE
• D7701377663: T CONNECT FOR SINGLE CROWN-2, DEEP 0.5 D.4.25 LARGE
• D7701377653: T CONNECT FOR SINGLE CROWN-2, DEEP 0.5 D.3.80 SMALL