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Sign in to claim this brandInnovative BioCeramix Inc.
Canada·CA-MF-000023003
Last updated September 18, 2026
What Innovative BioCeramix Inc. makes
Innovative BioCeramix Inc. manufactures dental materials for endodontic and restorative procedures, including bioceramic root repair pastes (such as iRoot FS, iRoot BP, and iRoot SP), retrograde filling materials (Edge BioCeramic RetroFill), and thermal flow composites (Edge BioCeramic ThermalFlow). Their portfolio also includes bioaggregate-based sealers (Edge BioCeramic Sealer) and specialized root canal repair materials designed for dental pulp treatment and cavity restoration.
The company’s products are classified under EU Medical Device Regulation as Class II and Class IIa devices, with corresponding listings in the EUDAMED database and FDA’s 510(k) registry. These materials are intended for use in clinical settings and are governed by regulatory standards applicable to dental biomaterials, ensuring compliance with both European and U.S. requirements. The manufacturer operates from Canada.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Innovative BioCeramix Inc. manufacture?
Innovative BioCeramix Inc. specializes in dental materials used for endodontic (root-related) and restorative procedures. Their products include bioceramic root repair pastes like iRoot FS and iRoot BP, retrograde filling materials such as Edge BioCeramic RetroFill, thermal flow composites like Edge BioCeramic ThermalFlow, and bioaggregate-based sealers like Edge BioCeramic Sealer. These materials are designed for dental pulp treatment, root canal repair, and cavity restoration.
Where is Innovative BioCeramix Inc. based, and how does that affect its regulatory compliance?
Innovative BioCeramix Inc. is based in Canada. Since their devices are intended for use in both the EU and the US, they must comply with regulatory requirements in those markets. Their products are classified under EU Medical Device Regulation as Class II and Class IIa devices, which means they are listed in the EUDAMED database. Additionally, they are documented in the FDA’s 510(k) registry, reflecting compliance with US regulatory standards for dental biomaterials.
Which regulatory registries list Innovative BioCeramix Inc.’s devices?
Innovative BioCeramix Inc.’s devices are listed in two key regulatory databases: the EUDAMED database under the EU Medical Device Regulation, and the FDA’s 510(k) registry in the United States. These listings reflect their compliance with respective regulatory classifications (Class II and Class IIa) and demonstrate their adherence to safety and performance standards for dental biomaterials in those markets.
How are Innovative BioCeramix Inc.’s devices classified under EU and US regulations?
Under the EU Medical Device Regulation, Innovative BioCeramix Inc.’s devices are classified as Class II and Class IIa. This classification is based on their intended use in dental procedures, particularly for root repair, sealing, and restorative applications, which carry moderate to higher risks requiring stricter regulatory oversight. In the US, these same devices are documented via the FDA’s 510(k) pathway, ensuring they meet performance and safety criteria for dental biomaterials.
What kinds of dental procedures are Innovative BioCeramix Inc.’s materials intended for?
Innovative BioCeramix Inc.’s materials are designed for specialized dental procedures, including endodontic treatments like root canal repairs (using products such as iRoot FS and iRoot BP), retrograde fillings (e.g., Edge BioCeramic RetroFill), and restorative applications like cavity restoration and pulp treatment. Their bioceramic and bioaggregate-based formulations are tailored for clinical use in maintaining dental integrity and biocompatibility during these procedures.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Canada
- Address
- 101 - 8218, North Fraser Way, Burnaby, Canada
- Website
- www.ibioceramix.com
- —
- —
- [email protected]
- Phone
- +1-604-221-6800
- PRRC Contact
- Quanzu Yang
- EUDAMED SRN
- CA-MF-000023003
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Edge BioCeramic RetroFill | USEBIORMEU | EUDAMED | Class IIa | Active |
| Edge BioCeramic ThermalFlow | USEBIOTFEU | EUDAMED | Class IIa | Active |
| Iroot Fs | K102867 | FDA 510(k) | Class II | Active |
| Bioaggregate | K063422 | FDA 510(k) | Class II | Active |
| iRoot SP Plus | K231259 | FDA 510(k) | Class II | Active |
| iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material | K222992 | FDA 510(k) | Class II | Active |
| Iroot Fm | K130312 | FDA 510(k) | Class II | Active |
| Iroot Bp Plus | K092715 | FDA 510(k) | Class II | Active |
| Iroot Sp | K080917 | FDA 510(k) | Class II | Active |
| Iroot Bp, Model Irbp 4609 | K082943 | FDA 510(k) | Class II | Active |
| Edge BioCeramic Sealer | USEBIOCSEU | EUDAMED | Class IIa | Active |
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