Swell™ Dental Implant 6.0D 6.25L

GUDID 07290105150431

ADIN DENTAL IMPLANT SYSTEMS LTD

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 07290105150431
• NIH Device Record Key: 31e5f469-3784-4730-bf03-3d3f88d72ea4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swell™ Dental Implant 6.0D 6.25L
• Version Model Number: ID0660
• 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	07290105150431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212775

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: 2022-07-25
• Device Publish Date: 2022-07-17

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