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-Repair of Root Perforation -Repair of Root Resorption -Root End Filling -Apexification -Pulp capping -Pulpotomy of primary teeth in the children (ages >2-12 years) and adolescent (ages >12-21 years).

iRoot BP, iRoot FS, and iRoot BP Plus are a convenient ready-to-use fast setting white hydraulic premixed bioceramic paste. Which are developed for permanent root canal repair of root perorption, and root end filling, apexification and pulp capping applications in adult and pediatric cases. The aforementioned products are an insoluble, radiopaque and aluminum-free material based on a calcium slicate composition, which requires the presence of water to set and harden. The products do not shrink during setting and demonstrate excellent physical properties. Root BP is packaged in a preloaded syringe, iRoot BP Plus is packaged in a preloaded container and iRoot FS is available both in syringe and container form. The devices have not changed from their respective predicate devices of iRoot BP(K082943), iRoot BP Plus(K092715), and iRoot FS(K102867).

For use in the treatment of root canals, or following pulpectomy, or for the apexogenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha. These indications include application in: - Apexification - Periapical Lesions - Root Resorption ● - Temporary Root Filling ● - Perforations ● - Underdeveloped pulpless teeth ●

iRoot FM Injectable Root Canal Filling Material (iRoot FM) is a convenient premixed ready-to-use injectable, radiopaque, white hydraulic bioceramic paste developed for root canal filling applications. iRoot FM is an aluminum-free material based on a calcium silicate composition, which requires the presence of water to set. iRoot FM is packaged in a pre-loaded syringe and is supplied with disposable tips.

Repair of Root Perforation Repair of Root Resorption Root End Filling Apexification Pulp Capping

iRoot FS Fast Set Root Repair Material (iRoot FS) is a convenient ready-to-use fast setting white hydraulic premixed bioceramic paste developed for permanent root canal repair of root perforation and root resorption, and root end filling, apexification and pulp capping applications. iRoot FS 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 FS does not shrink during setting and demonstrates excellent physical properties. iRoot FS is available as a preloaded syringe with disposable tips and a preloaded container.

- Repair of Root Perforation - Repair of Root Resorption - Root End Filling - Apexification - Pulp Capping

iRoot BP Plus Root Repair Material (iRoot BP Plus) is a convenient ready-to-use white hydraulic premixed bioceramic paste developed for permanent root canal repair and surgical applications. iRoot BP Plus 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 BP does not shrink during setting and demonstrates excellent physical properties. iRoot BP Plus is packaged in a preloaded container.

- Repair of Root Perforation - Repair of Root Resorption - Root End Filling - Apexification - Pulp Capping

iRoot BP Injectable Root Canal Repair Filling Material (iRoot BP) is a convenient ready-to-use white hydraulic premixed injectable BioAggregate paste developed for permanent root canal repair and filling applications. iRoot BP 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 BP does not shrink during setting and demonstrates excellent physical properties. iRoot BP is packaged in a preloaded syringe and is supplied with disposable tips.

- Permanent obturation of the root canal following vital pulp-extirpation. - Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings. iRoot SP is suitable for use in the single cone and lateral condensation technique.

iRoot SP 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 pre-loaded syringe and is supplied with disposable Intra Canal Tips.

Repair of Root Perforations Repair of Root Resorption Root End Filling Apexification Pulp capping

BioAggregate is a white hydraulic cement-like powder composed of biocompatible ceramic particles. The BioAggregate Powder promotes cementogenesis upon mixing with BioA Liquid and forms a hermetic seal inside the root canal.