IRIS™ RP CloseFit™ Kit, RH 4mm GH 3mm

GUDID 07290109301358

ADIN DENTAL IMPLANT SYSTEMS LTD

Dental implant suprastructure kit Dental implant suprastructure kit Dental implant suprastructure kit Dental implant suprastructure kit Dental implant suprastructure kit Dental implant suprastructure kit Dental implant suprastructure kit Dental implant suprastructure kit Dental implant suprastructure kit Dental implant suprastructure kit Dental implant suprastructure kit Dental implant suprastructure kit Dental implant suprastructure kit Dental implant suprastructure kit Dental implant suprastructure kit Dental implant suprastructure kit Dental implant suprastructure kit

• Primary Device ID: 07290109301358
• NIH Device Record Key: 9e75b918-85ca-4743-b20a-01a130af8332
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRIS™ RP CloseFit™ Kit, RH 4mm GH 3mm
• Version Model Number: IR3043
• 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	07290109301358 [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

[07290109301358]

Moist Heat or Steam Sterilization

[07290109301358]

Moist Heat or Steam Sterilization

[07290109301358]

Moist Heat or Steam Sterilization

[07290109301358]

Moist Heat or Steam Sterilization

[07290109301358]

Moist Heat or Steam Sterilization

[07290109301358]

Moist Heat or Steam Sterilization

[07290109301358]

Moist Heat or Steam Sterilization

[07290109301358]

Moist Heat or Steam Sterilization

[07290109301358]

Moist Heat or Steam Sterilization

[07290109301358]

Moist Heat or Steam Sterilization

[07290109301358]

Moist Heat or Steam Sterilization

[07290109301358]

Moist Heat or Steam Sterilization

[07290109301358]

Moist Heat or Steam Sterilization

[07290109301358]

Moist Heat or Steam Sterilization

[07290109301358]

Moist Heat or Steam Sterilization

[07290109301358]

Moist Heat or Steam Sterilization

[07290109301358]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-01
• Device Publish Date: 2021-03-24

Devices Manufactured by ADIN DENTAL IMPLANT SYSTEMS LTD

• 07290116770338 - Twist Step Drill 3.2/3.9mmD x 6-13mmL: 2024-06-06
• 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