Swell™ Dental Implant 5.0D 11.5L

GUDID 07290105150578

ADIN DENTAL IMPLANT SYSTEMS LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 07290105150578
• NIH Device Record Key: 94a7f657-8a0a-49bb-b76a-139b087f569d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swell™ Dental Implant 5.0D 11.5L
• Version Model Number: ID1150
• 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	07290105150578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081751

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: 2015-09-10

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