Touareg CloseFit™ UNP Dental Implant 2.75D 16L

GUDID 07290105152084

ADIN DENTAL IMPLANT SYSTEMS LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 07290105152084
• NIH Device Record Key: fe52c932-08c1-44ed-bfe2-f982888485f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Touareg CloseFit™ UNP Dental Implant 2.75D 16L
• Version Model Number: ISPUNP1627
• Company DUNS: 533289435
• Company Name: ADIN DENTAL IMPLANT SYSTEMS LTD
• 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: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290105152084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153111

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-18

Devices Manufactured by ADIN DENTAL IMPLANT SYSTEMS LTD

• 07290109308746 - NP Straight Single TMA 1mm: 2024-02-12
• 07290109308753 - NP Straight Single TMA 2mm: 2024-02-12
• 07290109308760 - NP Straight Single TMA 3mm: 2024-02-12
• 07290109308777 - NP Angled Single TMA 17° 3mm: 2024-02-12
• 07290109308784 - NP Angled Single TMA 30° 3.5mm: 2024-02-12
• 07290109308791 - NP Angled Single TMA 30° 5mm: 2024-02-12
• 07290109308807 - NP Angled Single TMA 17° 4mm: 2024-02-12
• 07290109308814 - NP Straight Single TMA 4mm: 2024-02-12