One-Fil Putty Injectable
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251884 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 One-Fil Putty Injectable is a premixed bioceramic cement designed for permanent root canal filling. It is formulated with a tricalcium silicate composition that sets and hardens in the presence of moisture, providing a durable seal within the root canal system.
This device is supplied as a single-use, non-sterile material intended for dental use under aseptic conditions. It is classified as a Class II medical device under FDA regulations (product code KIF) and has received FDA 510(k) clearance. The material is packaged for direct application in endodontic procedures and is not intended for MRI use.
Frequently asked questions
What is the One-Fil Putty Injectable specifically designed for in dental procedures?
The One-Fil Putty Injectable is a premixed bioceramic cement specifically formulated for permanent root canal filling. Its tricalcium silicate composition sets and hardens in the presence of moisture, creating a durable seal within the root canal system to prevent reinfection and leakage.
Is the One-Fil Putty Injectable sterile, and how should it be handled before use?
The One-Fil Putty Injectable is supplied as a non-sterile material, meaning it must be used under aseptic conditions in dental procedures. Clinicians should follow standard sterilization protocols for the tools and environment before application to ensure safety and efficacy.
Can this product be reused, or is it intended for single-use only?
The One-Fil Putty Injectable is explicitly labeled as a single-use product. Once opened or applied, it should not be reused to maintain sterility and performance standards for root canal treatment.
What regulatory pathways has the One-Fil Putty Injectable followed, and what classification does it hold?
The One-Fil Putty Injectable is classified as a Class II medical device under FDA regulations (product code KIF) and has received FDA 510(k) clearance (K251884). It was also evaluated under the Medical Device Directive (MDD) in its regulatory route, confirming its compliance for dental use in the U.S. and EU markets.
Is the One-Fil Putty Injectable safe for use in MRI environments?
No, the One-Fil Putty Injectable is not intended for MRI use. The manufacturer explicitly states it should not be applied in procedures involving magnetic resonance imaging due to potential compatibility risks with the material.
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: One-Fil®Putty | MEDICLUS, One-Fil® Putty Injectable | MEDICLUS, PDF Regulatory Affairs Team Manager Trade/Device Name: One-Fil Putty ..., K251884 - One-Fil Putty Injectable - FDA 510 (k)
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K251884 | Class II | Active |
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Manufacturer
- Manufacturer
- MEDICLUS Co., Ltd.
Sources (2)
- FDA 510(k) K251884 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026