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510(k) Data Aggregation
K Number
K201222Device Name
Bio-C Repair Ion+
Manufacturer
Angelus Industria de Produtos Odontologicos S/A
Date Cleared
2021-02-11
(281 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Angelus Industria de Produtos Odontologicos S/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- · Furcation or root perforation treatment via canal;
- · Furcation or root perforation treatment via surgical;
- · Internal reabsorption treatment via canal or surgical;
- · External reabsorption treatment;
- · Retrofilling in parendodontic surgery;
- · Direct and indirect pulp capping;
· Apexification;
- · Apexogenesis and Pulpotomy.
Device Description
BIO-C REPAIR ION+ is a bioceramic reparative material ready-to-use suitable for furcation or root perforation treatment via canal, furcation treatment via surgical, internal reabsorption treatment via canal or surgical, external reatment, retrofilling in parendodontic surgery, direct and indirect pulp capping, apexification, apexogenesis and pulpotomy.
The product is a single paste provided in a syringe with blunt tips to be applied into the root canal system. BIO-C REPAIR ION* is an insoluble and alkaline material, which requires the presence of water to set and harden. The product presents suitable radiopacity, demonstrating adequate physical properties inherent to root repair materials.
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K Number
K190537Device Name
BIO-C Sealer Ion+
Manufacturer
Angelus Industria de Produtos Odontologicos S/A
Date Cleared
2019-12-12
(283 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Angelus Industria de Produtos Odontologicos S/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Sealing the root canal of permanent teeth;
2. Internal reabsorption treatment.
Device Description
BIO-C SEALER ION* is a ready-to-use injectable bioceramic root canal sealer, developed for sealing the root canals and for the treatment of internal reabsorption. The product is a single paste provided in a syringe with disposable intracanal tips to be applied directly into the root canal system. BIO-C SEALER ION* is an insoluble and alkaline material, which requires the presence of water to set and harden. The product presents suitable radiopacity, demonstrating adequate physical properties inherent to root canal sealer materials.
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K Number
K180199Device Name
BIO-C TEMP
Manufacturer
Angelus Industria de Produtos Odontologicos S/A
Date Cleared
2019-01-04
(345 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Angelus Industria de Produtos Odontologicos S/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Intracanal dressing for endodontic treatment of pulp necrosis and retreatments.
- Intracanal dressing in cases of perforations, external and internal resorptions, prior to the use of MTA ANGELUS OR MTA REPAIR HP.
- For the treatment of incomplete root formation (rizogenesis):
Apexification - the formation of the apex in cases of pulp necrosis;
Apexigenesis - the formation of the apex in cases of vital pulp.
Device Description
Not Found
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K Number
K180185Device Name
BIO-C REPAIR
Manufacturer
Angelus Industria de Produtos Odontologicos S/A
Date Cleared
2018-08-31
(220 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Angelus Industria de Produtos Odontologicos S/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reparative cement for endodontic complications.
1. Furcation or root perforation treatment via canal;
2. Furcation or root perforation treatment via surgical;
3. Internal reabsorption treatment via canal or surgical;
4. External reabsorption treatment;
5. Retrofilling in parendodontic surgery;
6. Direct and indirect pulp capping;
7. Apexification;
8. Apexogenesis and Pulpotomy.
Device Description
BIO-C REPAIR is a ready-to-use bioceramic MTA-based paste developed for permanent root canal repair and surgical applications. The product is a single paste provided in a syringe with disposable tips to be applied to the affected area of the root canal system. BIO-C REPAIR is an insoluble and radiopaque material which requires the presence of water to set and harden.
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K Number
K172701Device Name
BIO-C SEALER
Manufacturer
Angelus Industria de Produtos Odontologicos S/A
Date Cleared
2018-01-04
(119 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Angelus Industria de Produtos Odontologicos S/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Sealing the root canal of permanent teeth;
- Internal reabsorption treatment;
Device Description
BIO-C SEALER is a ready-to-use injectable endodontic bioceramic sealer, suitable for obturation of root canals.
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