RADIOPAQUE INTRAORAL SCAN BODY; ABUTMENT; Ø3.5 PLATFORM

GUDID 08435389828860

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, temporary, preformed, reusable

• Primary Device ID: 08435389828860
• NIH Device Record Key: c999553b-ebc5-4e3b-856f-be12a7e43181
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RADIOPAQUE INTRAORAL SCAN BODY; ABUTMENT; Ø3.5 PLATFORM
• Version Model Number: SBIRMIUPE
• 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	08435389828860 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[08435389828860]

Moist Heat or Steam Sterilization

[08435389828860]

Moist Heat or Steam Sterilization

[08435389828860]

Moist Heat or Steam Sterilization

[08435389828860]

Moist Heat or Steam Sterilization

[08435389828860]

Moist Heat or Steam Sterilization

[08435389828860]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-23
• Device Publish Date: 2025-04-15

Devices Manufactured by BIOTECHNOLOGY INSTITUTE SL

• 08435389827559 - SURGICAL GUIDE SLEEVE BTI: 2025-04-23
• 08435389828174 - INTERNA 3.0 SURGICAL GUIDE SLEEVE BTI: 2025-04-23
• 08435389828822 - RADIOPAQUE INTRAORAL SCAN BODY; MULTI-IM ABUTMENT; Ø5.5 PLATFORM: 2025-04-23
• 08435389828839 - RADIOPAQUE INTRAORAL SCAN BODY; MULTI-IM ABUTMENT; Ø3.5 PLATFORM: 2025-04-23
• 08435389828846 - RADIOPAQUE INTRAORAL SCAN BODY; MULTI-IM ABUTMENT; Ø4.1 PLATFORM: 2025-04-23
• 08435389828853 - RADIOPAQUE INTRAORAL SCAN BODY; UNIT ABUTMENT; Ø5.5 PLATFORM: 2025-04-23
• 08435389828860 - RADIOPAQUE INTRAORAL SCAN BODY; ABUTMENT; Ø3.5 PLATFORM: 2025-04-23
• 08435389828860 - RADIOPAQUE INTRAORAL SCAN BODY; ABUTMENT; Ø3.5 PLATFORM: 2025-04-23
• 08435389828877 - RADIOPAQUE INTRAORAL SCAN BODY; ABUTMENT; Ø4.1 PLATFORM: 2025-04-23