IRIS™ WP CloseFit™ Kit, RH 6mm GH 1mm

GUDID 07290109301570

ADIN DENTAL IMPLANT SYSTEMS LTD

Dental implant suprastructure kit

• Primary Device ID: 07290109301570
• NIH Device Record Key: 160d6f85-0346-492f-a2e0-f292b7707ff8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRIS™ WP CloseFit™ Kit, RH 6mm GH 1mm
• Version Model Number: IR5061
• 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: true
• 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	07290109301570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112585

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

[07290109301570]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-07
• Device Publish Date: 2021-04-29

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• 07290116770468 - RS Angled Trans Mucosal Abutment Gauge 30°: 2024-08-28
• 07290116770475 - RS Angled Trans Mucosal Abutment Gauge 45°: 2024-08-28
• 07290116770482 - RS Angled Trans Mucosal Abutment Gauge 52°: 2024-08-28
• 07290116770499 - RS Angled Trans Mucosal Abutment Gauge 60°: 2024-08-28
• 07290116770505 - Long surgical driver: 2024-08-28