EdgeUtopia Bioceramic Sealer 38231

GUDID 07898078654644

Ready to use endodontic bioceramic obturator cement.

Angelus Industria de Produtos Odontologicos S A

Hygroscopic dental cement

• Primary Device ID: 07898078654644
• NIH Device Record Key: 5c78780e-184a-4251-b982-1a954b82999d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeUtopia Bioceramic Sealer
• Version Model Number: EdgeUtopia Bioceramic Sealer 2 g
• Catalog Number: 38231
• 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
• Phone: +554321013200
• Email: sac@angelus.ind.br
• Phone: +554321013200
• Email: sac@angelus.ind.br

Device Identifiers

Device Issuing Agency	Device ID
GS1	07898078654644 [Primary]

FDA Product Code

• KIF: Resin, Root Canal Filling

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: 2023-12-01
• Device Publish Date: 2023-11-23

Devices Manufactured by Angelus Industria de Produtos Odontologicos S A

• 07898078659939 - Komet BioRepair: 2024-12-04 Bioceramic reparative material ready-to-use.
• 08404535006025 - BC Sealer Ion+: 2024-10-23 Bioceramic root canal sealer ready to use.
• 08404535006414 - BC Sealer Ion+: 2024-10-23 Bioceramic root canal sealer ready to use.
• 08404535006445 - BC Sealer Ion+: 2024-10-23 Bioceramic root canal sealer ready to use.
• 07898078651605 - PURE-Ca-SEAL: 2024-10-22 Bioceramic root canal sealer ready-to-use.
• 07898078652701 - Komet BioRepair: 2024-10-22 Bioceramic reparative material ready-to-use.
• 07898078654996 - EdgeUtopia Repair Material: 2024-10-22 Bioceramic reparative material ready-to-use.
• 07898078655191 - EdgeUtopia Repair Material: 2024-10-22 Bioceramic reparative material ready-to-use.