EXTERNA® UNIVERSAL IMPLANT ANALOG

GUDID 08435389826132

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, temporary, preformed, reusable

• Primary Device ID: 08435389826132
• NIH Device Record Key: 36ac3786-217b-40ee-a069-923b4e12a4a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXTERNA® UNIVERSAL IMPLANT ANALOG
• Version Model Number: RLIU
• Company DUNS: 461665312
• Company Name: BIOTECHNOLOGY INSTITUTE SL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08435389826132 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-05
• Device Publish Date: 2025-04-25

On-Brand Devices [EXTERNA® UNIVERSAL IMPLANT ANALOG]

• 08435389800262: RLIU
• 08435389826132: RLIU