EXTERNA® UNIVERSAL PLATFORM CERAMIC-ON® TITANIUM ABUTMENT

GUDID 08435389801108

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08435389801108
• NIH Device Record Key: 594acd1f-3b12-4f2b-bdc8-a37e6324838f
• Commercial Distribution Discontinuation: 2017-06-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: EXTERNA® UNIVERSAL PLATFORM CERAMIC-ON® TITANIUM ABUTMENT
• Version Model Number: PPCTU
• 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 Millimeter
• Length: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 1 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08435389801108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022258

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[08435389801108]

Moist Heat or Steam Sterilization

[08435389801108]

Moist Heat or Steam Sterilization

[08435389801108]

Moist Heat or Steam Sterilization

[08435389801108]

Moist Heat or Steam Sterilization

[08435389801108]

Moist Heat or Steam Sterilization

[08435389801108]

Moist Heat or Steam Sterilization

[08435389801108]

Moist Heat or Steam Sterilization

[08435389801108]

Moist Heat or Steam Sterilization

[08435389801108]

Moist Heat or Steam Sterilization

[08435389801108]

Moist Heat or Steam Sterilization

[08435389801108]

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

• 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