Edge BioCeramic Sealer

Primary DI

07540276312016

Basic UDI-DI Code

7540276SP4608RA

Reference

USEBIOCSEU

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Innovative BioCeramix Inc.

iRoot SP Injectable Root Canal Sealer (iRoot SP) is a convenient premixed ready-to-use, injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. iRoot SP is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot SP does not shrink during setting and demonstrates excellent physical properties. iRoot SP is packaged in a preloaded syringe and is supplied with disposable Intra Canal tips.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).