Touareg UniFit Dental Implant 4.3D 16L

GUDID 07290109303208

ADIN DENTAL IMPLANT SYSTEMS LTD

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• Primary Device ID: 07290109303208
• NIH Device Record Key: 35e653de-8329-4e1a-bf7d-3362638f81ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Touareg UniFit Dental Implant 4.3D 16L
• Version Model Number: ISPUF1643
• Company DUNS: 533289435
• Company Name: ADIN DENTAL IMPLANT SYSTEMS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	07290109303208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223714

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-11
• Device Publish Date: 2024-01-03

Devices Manufactured by ADIN DENTAL IMPLANT SYSTEMS LTD

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• 07290116770345 - Twist Step Drill 3.2/3.9mmD x 8-18mmL: 2024-06-06
• 07290109307824 - UniFit Star Torque Driver-Short: 2024-04-29
• 07290109307831 - UniFit Star Torque Driver-Long: 2024-04-29
• 07290109307848 - UniFit Ratchet Retrieval Tool for Abutments: 2024-04-29
• 07290116770284 - UniFit Ratchet Retrieval Tool: 2024-04-29
• 07290116770321 - Guided UniFit Ratchet Fixture Mount S-5.5: 2024-04-29
• 07290116770352 - Guided UniFit Ratchet Fixture Mount S-5.5, Screw Retained: 2024-04-29