One-Fil Putty

One-Fil Putty is a Class II dental product purposed as a permanent root canal filling repair material for extensive endodontic applications. Its science is rooted in its tricalcium aluminate compound composition, functioning as a premixed, moisture-hardening paste with adhesive properties, validated by non-clinical data for substantial equivalence.

The "One-Fil Putty" manufactured by Mediclus Co., Ltd. has been deemed substantially equivalent to existing legally marketed predicate devices, enabling its market availability as a Class II dental product. This decision is contingent upon adherence to general controls such as annual registration, device listing, and good manufacturing practices, with potential additional controls depending on its specific classification. Its primary purpose is as a permanent root canal filling repair material, functioning as a dental root canal sealer for various endodontic procedures. "One-Fil Putty" is characterized as a premixed, white paste primarily composed of tricalcium aluminate compounds. The device's scientific mechanism relies on its ability to harden upon exposure to moisture, facilitating its adhesive and workable properties crucial for its application in root canal repair. Its broad indications include treatment for furcation or root perforations, internal and external reabsorption, retrofilling in parendodontic surgery, direct and indirect pulp capping, apexification, apexogenesis, and pulpotomy. The substantial equivalence finding was substantiated by comprehensive non-clinical performance data, including tests complying with ISO standards for mechanical properties and biocompatibility, affirming its alignment in intended use, technological characteristics, and material composition with its predicate device.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific clinical long-term performance data, beyond non-clinical studies, supports the durability and effectiveness of "One-Fil Putty" in human subjects?; How do the moisture-hardening properties and tricalcium aluminate compounds of "One-Fil Putty" compare to other contemporary bioceramic sealers regarding setting time, dimensional stability, and bond strength to dentin?; Are there any contraindications or specific patient populations for whom "One-Fil Putty" might be less suitable, not covered by the current indications for use?; What is the degradation profile of "One-Fil Putty" over time within the root canal system, and how does it affect the potential for future retreatment or diagnostic imaging?; What post-market surveillance plans are in place to monitor potential adverse events or unexpected performance issues once "One-Fil Putty" is widely adopted for its various indicated uses?