i-MTA BP Bioceramic Root Canal Sealer and Repair Materials
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242934 FDA 510(k)
- FDA Product Code
- KIF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3820 FDA 510(k)
- Regulation Number
- 872.3820 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The i-MTA BP Bioceramic Root Canal Sealer and Repair Materials is a premixed bioceramic paste designed for permanent root canal sealing and surgical endodontic repair. Classified as a resin-based root canal filling material, it provides a radiopaque, insoluble, and aluminum-free solution for dental procedures requiring durable sealing and biocompatible repair.
This device is supplied as a ready-to-use paste and is intended for single-use in dental settings. It adheres to FDA 510(k) clearance (K242934) under regulation number 872.3820, classified as a Class II medical device. The material is composed of calcium silicate, zirconium oxide, tantalum pentoxide, and calcium sulfate, ensuring biocompatibility and radiopacity for precise imaging. Storage and handling follow standard dental material protocols to maintain sterility and efficacy.
Frequently asked questions
What is the i-MTA BP Bioceramic Root Canal Sealer used for?
The i-MTA BP Bioceramic Root Canal Sealer is designed for permanent root canal sealing and surgical endodontic repair. It provides a radiopaque, insoluble, and aluminum-free solution, ensuring durable sealing and biocompatible repair in dental procedures. Its composition of calcium silicate, zirconium oxide, tantalum pentoxide, and calcium sulfate supports both functionality and imaging clarity.
How is the i-MTA BP Bioceramic Root Canal Sealer supplied, and is it single-use?
The i-MTA BP Bioceramic Root Canal Sealer is supplied as a ready-to-use premixed paste, eliminating the need for on-site mixing. It is intended for single-use in dental settings to ensure sterility and prevent cross-contamination, adhering to standard dental material protocols.
Is the i-MTA BP Bioceramic Root Canal Sealer sterile, and how should it be stored?
The i-MTA BP Bioceramic Root Canal Sealer is supplied in a sterile, ready-to-use format to maintain efficacy and safety. Storage should follow standard dental material protocols, typically in a cool, dry place away from direct sunlight, and sealed packaging should remain intact until use to preserve sterility.
What materials does the i-MTA BP Bioceramic Root Canal Sealer contain, and why are they important?
The i-MTA BP Bioceramic Root Canal Sealer contains calcium silicate, zirconium oxide, tantalum pentoxide, and calcium sulfate. These materials ensure biocompatibility, radiopacity (for clear imaging), and mechanical strength, making it suitable for long-term sealing and repair in root canal treatments.
What regulatory clearance does the i-MTA BP Bioceramic Root Canal Sealer hold?
The i-MTA BP Bioceramic Root Canal Sealer holds FDA 510(k) clearance under the classification of a Class II medical device, specifically under regulation number 872.3820. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory standards for dental root canal filling materials.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) (K242934 ..., Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP), Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242934 | Class II | Active |
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Manufacturer
- Manufacturer
- Longly Biotechnology (Wuhan) Co., Ltd.
Sources (1)
- FDA 510(k) K242934 24 fields · synced Oct 5, 2026