PERMA MESH 4429

GUDID 07898078659236

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: 07898078659236
• NIH Device Record Key: 930bb0fa-4cef-4cd3-84b1-7f7bfcd2a219
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERMA MESH
• Version Model Number: PERMA MESH 1 unit
• Catalog Number: 4429
• 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
• 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	07898078659236 [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

Devices Manufactured by Angelus Industria de Produtos Odontologicos S A

• 07898078650134 - SPEED GUN: 2025-03-28 System for application of dental materials.
• 07898078657423 - SPEED GUN: 2025-03-28 System for application of dental materials.
• 07898078659427 - EdgeUtopia RRM Dispensing Gun: 2025-03-28 System for application of dental materials.
• 07898078659465 - PURE-Ca-SEAL: 2025-03-28 Bioceramic root canal sealer ready-to-use.
• 07898078659236 - PERMA MESH: 2025-02-25Fiberglass material used for the reinforcement of dental prostheses and the splinting of teeth.
• 07898078659236 - PERMA MESH: 2025-02-25 Fiberglass material used for the reinforcement of dental prostheses and the splinting of teeth.
• 07898078659243 - E-FIBER: 2025-02-25 Fiberglass material used for the reinforcement of dental prostheses and the splinting of teeth.
• 07898078659267 - E-FIBER: 2025-02-25 Fiberglass material used for the reinforcement of dental prostheses and the splinting of teeth.
• 07898078659274 - E-FIBER: 2025-02-25 Fiberglass material used for the reinforcement of dental prostheses and the splinting of teeth.