BioRoot RCS

Trade name

BioRoot RCS

UDI-DI code

D-FR-MF-00001699200032PG

Basic UDI-DI

B-FR-MF-00001699200032PG

Reference / catalog number

245S - 309S

Issuing entity

EUDAMED

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

BioRoot™ RCS is a hydrophilic mineral root canal sealer prepared from the mixture of a powder part and a liquid part. BioRoot™ RCS is based on tricalcium silicate reaction with water to seal the root canal. The hydraulic nature of this sealer ensures a good adaptation to the root canal, tight interface with gutta-percha point and adequate radiopacity. It is an implantable medical device intended to be used in dentistry. It is part of endodontic cements used as permanent root canal sealer. BioRoot™ RCS is used in combination with gutta-percha points to fill the root canal.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 35 single doses of 0.20 mL liquid divided into 7 foils
• 1 bottle of 15 g powder

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Q01010202ROOT CANAL FILLING DENTAL CEMENTS

2 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.

No certificate specifically references this device's Basic UDI-DI.