UNIT, INTERNA® UNIVERSAL ABUTMENT 4 MM

GUDID 08435389813071

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08435389813071
• NIH Device Record Key: 85e17873-fc3a-48fd-b7af-238c2d9753a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIT, INTERNA® UNIVERSAL ABUTMENT 4 MM
• Version Model Number: INTMIUPU40
• 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: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08435389813071 [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: 2016-07-19

Devices Manufactured by BIOTECHNOLOGY INSTITUTE SL

• 08435389808497 - ANGULATED MULTI-IM® CASTABLE CYLINDER, TINY® & UNIVERSAL PLATFORM: 2024-08-07
• 08435389808510 - ANGULATED MULTI-IM® PROVISIONAL CYLINDER, TINY® & UNIVERSAL PLATFORM: 2024-08-07
• 08435389808541 - ANGULATED MULTI-IM® HEALING CAP, TINY® AND UNIVERSAL PLATFORM: 2024-08-07
• 08435389819271 - EXPANDED SQUARE AESTHETIC INTERFACE OF THE WIDE PLATFORM MULTI-IM: 2024-08-07
• 08435389821731 - INTERNA NARROW TO WIDE EXPANSION MULTI-IM ABUTMENT 4 MM: 2024-08-07
• 08435389821748 - INTERNA NARROW TO WIDE EXPANSION MULTI-IM ABUTMENT 5 MM: 2024-08-07
• 08435389822523 - ANGLED UNIT UNIVERSAL PLATFORM PROVISIONAL CYLINDER: 2024-08-07
• 08435389822554 - CASTABLE ABUTMENT FOR THE SQUARE AESTHETIC INTERFACE ANGLED UNIT OF THE UNIVERSA: 2024-08-07