EXTERNA ® UNIVERSAL IMPLANT IMPRESSION COPING - INDIRECT TECHNIQUE ROTATING Ø

GUDID 08435389824879

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, temporary, preformed, reusable

• Primary Device ID: 08435389824879
• NIH Device Record Key: 963c95f3-f4f1-439c-a44c-4caa9849df5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXTERNA ® UNIVERSAL IMPLANT IMPRESSION COPING - INDIRECT TECHNIQUE ROTATING Ø
• Version Model Number: CIRIU4
• 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: false
• Expiration Date: false
• 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	08435389824879 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[08435389824879]

Moist Heat or Steam Sterilization

[08435389824879]

Moist Heat or Steam Sterilization

[08435389824879]

Moist Heat or Steam Sterilization

[08435389824879]

Moist Heat or Steam Sterilization

[08435389824879]

Moist Heat or Steam Sterilization

[08435389824879]

Moist Heat or Steam Sterilization

[08435389824879]

Moist Heat or Steam Sterilization

[08435389824879]

Moist Heat or Steam Sterilization

[08435389824879]

Moist Heat or Steam Sterilization

[08435389824879]

Moist Heat or Steam Sterilization

[08435389824879]

Moist Heat or Steam Sterilization

[08435389824879]

Moist Heat or Steam Sterilization

[08435389824879]

Moist Heat or Steam Sterilization

[08435389824879]

Moist Heat or Steam Sterilization

[08435389824879]

Moist Heat or Steam Sterilization

[08435389824879]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-22
• Device Publish Date: 2025-04-14

Devices Manufactured by BIOTECHNOLOGY INSTITUTE SL

• 08435389828952 - EXTRACTOR FOR IMPLANTS 8: 2026-02-09
• 08435389828969 - EXTRACTOR FOR IMPLANTS 9: 2026-02-09
• 08435389829027 - SHORT DRILL; Ø2,2 MM: 2026-02-09
• 08435389829034 - SHORT DRILL; Ø2,3 MM: 2026-02-09
• 08435389829041 - SHORT DRILL; Ø2,4 MM: 2026-02-09
• 08435389829058 - SHORT DRILL; Ø2,0 MM: 2026-02-09
• 08435389829096 - FLATTENING FRONT CUTTING SHORT DRILL; Ø5.5: 2026-02-09
• 08435389830061 - EXTRA SHORT INITIAL DRILL: 2026-02-09