IRIS™ RP Snap-on Impression Kit, RH 4mm GH 4mm

GUDID 07290109301488

ADIN DENTAL IMPLANT SYSTEMS LTD

Dental implant suprastructure kit

• Primary Device ID: 07290109301488
• NIH Device Record Key: 26c03d2f-c560-4e0b-8fa1-2982a259362d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRIS™ RP Snap-on Impression Kit, RH 4mm GH 4mm
• Version Model Number: IR3144
• 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	07290109301488 [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

[07290109301488]

Moist Heat or Steam Sterilization

[07290109301488]

Moist Heat or Steam Sterilization

[07290109301488]

Moist Heat or Steam Sterilization

[07290109301488]

Moist Heat or Steam Sterilization

[07290109301488]

Moist Heat or Steam Sterilization

[07290109301488]

Moist Heat or Steam Sterilization

[07290109301488]

Moist Heat or Steam Sterilization

[07290109301488]

Moist Heat or Steam Sterilization

[07290109301488]

Moist Heat or Steam Sterilization

[07290109301488]

Moist Heat or Steam Sterilization

[07290109301488]

Moist Heat or Steam Sterilization

[07290109301488]

Moist Heat or Steam Sterilization

[07290109301488]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-20
• Device Publish Date: 2021-04-12

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