INTERNA UNIVERSAL TO WIDE EXPANSION UNIT ABUTMENT 3.5 MM

GUDID 08435389818175

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08435389818175
• NIH Device Record Key: 03e1dba2-1e72-45cf-bdea-41cd822bebbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTERNA UNIVERSAL TO WIDE EXPANSION UNIT ABUTMENT 3.5 MM
• Version Model Number: INTMIUPUEX35
• 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

• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter
• Height: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08435389818175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061383

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-07-27

Devices Manufactured by BIOTECHNOLOGY INSTITUTE SL

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• 08435389829140 - INTERNA HEALING ABUTMENT; 3.0 PLATFORM; Ø3; H 2mm: 2025-09-10
• 08435389829102 - SCANNABLE LABORATORY ANALOG; MULTI-IM; Ø3.5 PLATFORM: 2025-06-18
• 08435389829119 - SCANNABLE LABORATORY ANALOG; MULTI-IM; Ø5.5 PLATFORM: 2025-06-18
• 08435389829126 - SCANNABLE LABORATORY ANALOG; MULTI-IM; Ø4.1 PLATFORM: 2025-06-18
• 08435389828815 - APPLICATOR CONNECTOR; INTERNA IMPLANT; 3.0 PLATFORM; 24 MM: 2025-05-27
• 08435389826156 - UNIT, ANALOGUE, Ø3.5 PLATFORM: 2025-05-06
• 08435389826163 - MULTI-IM® ANALOG, TINY® & UNIVERSAL PLATFORM: 2025-05-06