HEXED EXTERNA® TITANIUM SCREW, DIRECT PROSTHESIS

GUDID 08435389809487

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08435389809487
• NIH Device Record Key: f279a95e-b6c8-4490-a716-8e9cc94beeee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEXED EXTERNA® TITANIUM SCREW, DIRECT PROSTHESIS
• Version Model Number: INTTUHR
• Company DUNS: 461665312
• Company Name: BIOTECHNOLOGY INSTITUTE SL
• Device Count: 1
• DM Exempt: true
• 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: false
• 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: 2156464067
• Email: christinebattilana@bti-implant.us
• Phone: 2156464067
• Email: christinebattilana@bti-implant.us
• Phone: 2156464067
• Email: christinebattilana@bti-implant.us
• Phone: 2156464067
• Email: christinebattilana@bti-implant.us
• Phone: 2156464067
• Email: christinebattilana@bti-implant.us
• Phone: 2156464067
• Email: christinebattilana@bti-implant.us
• Phone: 2156464067
• Email: christinebattilana@bti-implant.us
• Phone: 2156464067
• Email: christinebattilana@bti-implant.us
• Phone: 2156464067
• Email: christinebattilana@bti-implant.us
• Phone: 2156464067
• Email: christinebattilana@bti-implant.us
• Phone: 2156464067
• Email: christinebattilana@bti-implant.us

Device Dimensions

• Length: 5.3 Millimeter
• Outer Diameter: 1.8 Millimeter
• Length: 5.3 Millimeter
• Outer Diameter: 1.8 Millimeter
• Length: 5.3 Millimeter
• Outer Diameter: 1.8 Millimeter
• Length: 5.3 Millimeter
• Outer Diameter: 1.8 Millimeter
• Length: 5.3 Millimeter
• Outer Diameter: 1.8 Millimeter
• Length: 5.3 Millimeter
• Outer Diameter: 1.8 Millimeter
• Length: 5.3 Millimeter
• Outer Diameter: 1.8 Millimeter
• Length: 5.3 Millimeter
• Outer Diameter: 1.8 Millimeter
• Length: 5.3 Millimeter
• Outer Diameter: 1.8 Millimeter
• Length: 5.3 Millimeter
• Outer Diameter: 1.8 Millimeter
• Length: 5.3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08435389809487 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053355

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[08435389809487]

Moist Heat or Steam Sterilization

[08435389809487]

Moist Heat or Steam Sterilization

[08435389809487]

Moist Heat or Steam Sterilization

[08435389809487]

Moist Heat or Steam Sterilization

[08435389809487]

Moist Heat or Steam Sterilization

[08435389809487]

Moist Heat or Steam Sterilization

[08435389809487]

Moist Heat or Steam Sterilization

[08435389809487]

Moist Heat or Steam Sterilization

[08435389809487]

Moist Heat or Steam Sterilization

[08435389809487]

Moist Heat or Steam Sterilization

[08435389809487]

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: 2015-10-22

On-Brand Devices [HEXED EXTERNA® TITANIUM SCREW, DIRECT PROSTHESIS]

• 08435389809500: TTUHR
• 08435389809487: INTTUHR