INTERNA WIDE UNIT ABUTMENT 2 MM

GUDID 08435389815686

BIOTECHNOLOGY INSTITUTE SL

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• Primary Device ID: 08435389815686
• NIH Device Record Key: 25d4063d-52c3-4f93-aa6f-6075d3e279b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTERNA WIDE UNIT ABUTMENT 2 MM
• Version Model Number: INTMIUPA20
• 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: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08435389815686 [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: 2016-07-13

Devices Manufactured by BIOTECHNOLOGY INSTITUTE SL

• 08435389823803 - SHORT DRILL; Ø 6MM: 2023-08-30
• 08435389825296 - WIDE PLATFORM POSITIONER (2 UNITS): 2023-07-07
• 08435389825319 - TINY® PLATFORM POSITIONER (2 UNITS): 2023-07-07
• 08435389825333 - UNIVERSAL PLATFORM POSITIONER (2 UNITS): 2023-07-07
• 08435389825357 - UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS): 2023-07-07
• 08435389825364 - SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS): 2023-07-07
• 08435389825302 - SHORT POSITIONER FOR WIDE PLATFORM (2 UNITS): 2023-07-07
• 08435389825326 - SHORT POSITIONER FOR TINY® PLATFORM (2 UNITS): 2023-07-07