EXTERNA® UNIVERSAL ESTHETIC BIO ABUTMENT 3 MM

GUDID 08435389809975

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08435389809975
• NIH Device Record Key: b9b4b614-96cf-4133-9a25-8d81b7334e3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXTERNA® UNIVERSAL ESTHETIC BIO ABUTMENT 3 MM
• Version Model Number: PUTZ3
• 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

• Length: 3 Millimeter
• Outer Diameter: 4.1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.1 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.1 Millimeter
• Length: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08435389809975 [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

[08435389809975]

Moist Heat or Steam Sterilization

[08435389809975]

Moist Heat or Steam Sterilization

[08435389809975]

Moist Heat or Steam Sterilization

[08435389809975]

Moist Heat or Steam Sterilization

[08435389809975]

Moist Heat or Steam Sterilization

[08435389809975]

Moist Heat or Steam Sterilization

[08435389809975]

Moist Heat or Steam Sterilization

[08435389809975]

Moist Heat or Steam Sterilization

[08435389809975]

Moist Heat or Steam Sterilization

[08435389809975]

Moist Heat or Steam Sterilization

[08435389809975]

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

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• 08435389826156 - UNIT, ANALOGUE, Ø3.5 PLATFORM: 2025-05-06
• 08435389826163 - MULTI-IM® ANALOG, TINY® & UNIVERSAL PLATFORM: 2025-05-06