E-FIBER 4434

GUDID 07898078659298

Fiberglass material used for the reinforcement of dental prostheses and the splinting of teeth.

Angelus Industria de Produtos Odontologicos S A

Dental reinforcing fibre

• Primary Device ID: 07898078659298
• NIH Device Record Key: 32b8945d-6d09-43a2-9626-1ce320d7aecd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-FIBER
• Version Model Number: E-FIBER 10 cm 1.4 mm
• Catalog Number: 4434
• Company DUNS: 906943303
• Company Name: Angelus Industria de Produtos Odontologicos S A
• Device Count: 1
• DM Exempt: false
• 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: 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

Customer Support Contacts

• Phone: +554321013200
• Email: sac@angelus.ind.br
• Phone: +554321013200
• Email: sac@angelus.ind.br
• Phone: +554321013200
• Email: sac@angelus.ind.br
• Phone: +554321013200
• Email: sac@angelus.ind.br
• Phone: +554321013200
• Email: sac@angelus.ind.br
• Phone: +554321013200
• Email: sac@angelus.ind.br
• Phone: +554321013200
• Email: sac@angelus.ind.br
• Phone: +554321013200
• Email: sac@angelus.ind.br
• Phone: +554321013200
• Email: sac@angelus.ind.br
• Phone: +554321013200
• Email: sac@angelus.ind.br

Device Identifiers

Device Issuing Agency	Device ID
GS1	07898078659298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082180

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2025-02-25
• Device Publish Date: 2025-02-17

On-Brand Devices [E-FIBER]

• 07898078659403: Fiberglass material used for the reinforcement of dental prostheses and the splinting of teeth.
• 07898078659298: Fiberglass material used for the reinforcement of dental prostheses and the splinting of teeth.
• 07898078659281: Fiberglass material used for the reinforcement of dental prostheses and the splinting of teeth.
• 07898078659274: Fiberglass material used for the reinforcement of dental prostheses and the splinting of teeth.
• 07898078659267: Fiberglass material used for the reinforcement of dental prostheses and the splinting of teeth.
• 07898078659243: Fiberglass material used for the reinforcement of dental prostheses and the splinting of teeth.