Identifiers
- 510(k) Number
- K140955 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 MTA2.1 Material is a resin-based root canal filling material designed for use in dental procedures involving contact with vital pulp tissue and periradicular tissue. It is intended for applications such as pulp capping, cavity lining, base material, pulpotomy, and root-end filling, as well as sealing and obturation of root canals.
Supplied as a non-sterile, single-use material for dental clinical settings, the MTA2.1 Material is regulated under FDA 510(k) clearance (K140955) as a Class II device with product code KIF. It is not indicated for MRI safety assessment, and no sterility, storage, or reuse specifications are provided in the data.
Frequently asked questions
What is the MTA2.1 Material used for?
The MTA2.1 Material is a resin-based root canal filling material designed for use in dental procedures involving contact with vital pulp tissue and periradicular tissue. It is intended for applications such as pulp capping, cavity lining, base material, pulpotomy, and root-end filling, as well as sealing and obturation of root canals.
How is the MTA2.1 Material supplied and is it sterile or reusable?
The MTA2.1 Material is supplied as a non-sterile, single-use material for dental clinical settings. It is not indicated for reuse, and no sterility specifications are provided in the data, meaning it must be used as-is without reprocessing.
What regulatory pathway was used for the MTA2.1 Material?
The MTA2.1 Material is regulated under FDA 510(k) clearance (K140955) as a Class II device with product code KIF. This indicates it was found substantially equivalent to a legally marketed predicate device.
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: MTA2.1 MATERIAL by AVALON BIOMED INC. | FDA 510 (k) Summary, PDF Avolon Biomed Inc. 12014 - Food and Drug Administration, MTA2 ROOT AND PULP MATERIALS by AVALON BIOMED INC. | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140955 | Class II | Active |
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Manufacturer
- Manufacturer
- Avalon Biomed Inc.
- FDA Applicant
- Avalon Biomed, Inc.
Sources (1)
- FDA 510(k) K140955 24 fields · synced Sep 24, 2026