UNP CloseFit™ Ball Attachment 5mm

GUDID 07290105159748

ADIN DENTAL IMPLANT SYSTEMS LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07290105159748
• NIH Device Record Key: 1c9e3b51-74d0-4c50-b27e-e53c063eea87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNP CloseFit™ Ball Attachment 5mm
• Version Model Number: UNP0025
• 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: false
• 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	07290105159748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153111

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[07290105159748]

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: 2016-05-18

Devices Manufactured by ADIN DENTAL IMPLANT SYSTEMS LTD

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• 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