Angelus Industria de Produtos Odontologicos S A

Address:101, WALDIR LANDGRAF,LONDRINA Parana,BR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Resin, Root Canal Filling (KIF) (8)

Premarket Exempt

Clear

MTA-FILLAPEX - 07898078658277 Catalog Number : 827

Device Description : Bioceramic Root Canal Sealer - MTA-Fillapex 4gMTA-Fillapex is a bioceramic root Bioceramic Root Canal Sealer - MTA-Fillapex 4gMTA-Fillapex is a bioceramic root canal sealer based on MTA (mineral trioxide aggregate). Its composition provides long term sealing capacity, high radiopacity, promotes the stimulation of hard tissue formation in the dental apex and perforation sites, low expansion during setting, low solubility in contact with tissue fluids, excellent viscosity for insertion, does not stain the tooth, it is a eugenol-free material and has appropriate working time for endodontic procedures.

Device Class : 2

Duns Number: 906943303

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

BIO-C SEALER - 07898078658833 Catalog Number : 3823

Device Description : Ready-to-use Bioceramic Root Canal Sealer - BIO-C SEALER 2 g

Device Class : 2

Duns Number: 906943303

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

BIO-C TEMP - 07898078658840 Catalog Number : 2833

Device Description : Ready-to-use Bioceramic Paste for Intracanal Dressing - BIO-C TEMP 2 g

Device Class : 2

Duns Number: 906943303

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

BIO-C REPAIR - 07898078658864 Catalog Number : 3863

Device Description : Ready-to-use Bioceramic Reparative Material - BIO-C REPAIR 2 g

Device Class : 2

Duns Number: 906943303

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

BIO-C SEALER - 07898078659816 Catalog Number : 3822

Device Description : Ready-to-use Bioceramic Root Canal Sealer - BIO-C SEALER 0.5 g

Device Class : 2

Duns Number: 906943303

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

BIO-C SEALER ION+ - 07898078659823 Catalog Number : 3843

Device Description : Ready-to-use Bioceramic Root Canal Sealer - BIO-C SEALER ION+ 2 g

Device Class : 2

Duns Number: 906943303

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

BIO-C REPAIR - 07898078659847 Catalog Number : 3861

Device Description : Ready-to-use Bioceramic Reparative Material - BIO-C REPAIR 0.5 g

Device Class : 2

Duns Number: 906943303

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

BIO-C TEMP - 07898078659915 Catalog Number : 2832

Device Description : Ready-to-use Bioceramic Paste for Intracanal Dressing - BIO-C TEMP 0.5 g

Device Class : 2

Duns Number: 906943303

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

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