INTERNA® WIDE ESTHETIC ABUTMENT

GUDID 08435389809791

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08435389809791
• NIH Device Record Key: 8dcde5ae-8858-49fd-b386-9acdc0035ebc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTERNA® WIDE ESTHETIC ABUTMENT
• Version Model Number: INPATZ0
• 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

• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08435389809791 [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

[08435389809791]

Moist Heat or Steam Sterilization

[08435389809791]

Moist Heat or Steam Sterilization

[08435389809791]

Moist Heat or Steam Sterilization

[08435389809791]

Moist Heat or Steam Sterilization

[08435389809791]

Moist Heat or Steam Sterilization

[08435389809791]

Moist Heat or Steam Sterilization

[08435389809791]

Moist Heat or Steam Sterilization

[08435389809791]

Moist Heat or Steam Sterilization

[08435389809791]

Moist Heat or Steam Sterilization

[08435389809791]

Moist Heat or Steam Sterilization

[08435389809791]

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: 2015-10-17

Devices Manufactured by BIOTECHNOLOGY INSTITUTE SL

• 08435389826156 - UNIT, ANALOGUE, Ø3.5 PLATFORM: 2025-05-06
• 08435389826163 - MULTI-IM® ANALOG, TINY® & UNIVERSAL PLATFORM: 2025-05-06
• 08435389826170 - UNIT, ANALOGUE, UNIVERSAL PLATFORM: 2025-05-06
• 08435389826187 - MULTI-IM® ANALOG FOR WIDE PLATFORM: 2025-05-06
• 08435389826194 - UNIT, ANALOGUE, WIDE PLATFORM: 2025-05-06
• 08435389826200 - ANGULATED MULTI-IM® ANALOG, TINY® & UNIVERSAL PLATFORM: 2025-05-06
• 08435389826095 - INTERNA® NARROW IMPLANT ANALOGUE: 2025-05-05
• 08435389826101 - INTERNA® UNIVERSAL IMPLANT ANALOG: 2025-05-05