Titan Implant I2-3.5,13

GUDID 07290107270038

Screw Type Implant, 3.5 mm Diameter, 13 mm length

A.B. DENTAL DEVICES LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 07290107270038
• NIH Device Record Key: cd8cdc07-8b82-42d3-8e56-8644b775fea7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan Implant
• Version Model Number: I2-3.5,13
• Catalog Number: I2-3.5,13
• Company DUNS: 534128491
• Company Name: A.B. DENTAL DEVICES 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: true
• 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

Customer Support Contacts

• Phone: +972732454900
• Email: Info@ab-dent.com

Device Dimensions

• Length: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290107270038 [Primary]
GS1	17290107270035 [Package]; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132125

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-13
• Device Publish Date: 2019-05-05

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