RITENTION JACKET (4PS) FOR THE 8394

GUDID 00893202000882

RITENTION JACKET (4PS) FOR THE DRIVER FOR TRASF. LOC. ABUT.

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00893202000882
• NIH Device Record Key: 20e65241-d6db-4c6f-a246-d4db1698b116
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RITENTION JACKET (4PS) FOR THE
• Version Model Number: 8394
• Catalog Number: 8394
• 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
GS1	00893202000882 [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

[00893202000882]

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: 2016-08-05

Devices Manufactured by SWEDEN & MARTINA SPA

• D7700605273 - ANALOGUE FOR IMPLANT: 2024-04-04 ANALOGUE FOR IMPLANT OUTLINK2 D.3.30 MM
• D7701041173 - CLOSED TRAY TRANSFER: 2024-04-04 CLOSED TRAY TRANSFER OUTLINK2 ANATOMICAL PROF., D.3.30 MM
• D7701457803 - INTRAORAL SCANBODY: 2024-04-04 INTRAORAL SCANBODY D.3.30 MM
• D7701604673 - T-CONNECT FOR SINGLE: 2024-04-01 T-CONNECT FOR SINGLE HEIGHT 8 MM D.3,30 EX.2,30
• D7701604683 - T-CONNECT FOR SINGLE: 2024-04-01 T-CONNECT FOR SINGLE HEIGHT 8 MM D.3,30 EX.2,30 H 1 MM
• D7701604693 - T-CONNECT FOR SINGLE: 2024-04-01 T-CONNECT FOR SINGLE HEIGHT 8 MM D.3,30 EX.2,30 H 2 MM
• D7701604703 - T-CONNECT FOR SINGLE: 2024-04-01 T-CONNECT FOR SINGLE HEIGHT 8 MM D.3,30 EX.2,30 H 3 MM
• D7701604723 - T-CONNECT FOR SINGLE: 2024-04-01 T-CONNECT FOR SINGLE HEIGHT 8 MM D.3,80 EX.2,30