MTA-FILLAPEX - Bioceramic Root Canal Sealer - MTA-Fillapex - Angelus Industria de Produtos Odontologicos S A

Duns Number:906943303

Device Description: Bioceramic Root Canal Sealer - MTA-Fillapex 4gMTA-Fillapex is a bioceramic root canal seal 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.

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More Product Details

Catalog Number

827

Brand Name

MTA-FILLAPEX

Version/Model Number

MTA-Fillapex 4g

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KIF

Product Code Name

Resin, Root Canal Filling

Device Record Status

Public Device Record Key

1d28b194-6667-470f-acf7-55dac304fb24

Public Version Date

August 26, 2019

Public Version Number

1

DI Record Publish Date

August 16, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ANGELUS INDUSTRIA DE PRODUTOS ODONTOLOGICOS S A" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 18