# The Hidden Dangers of Counterfeit and Replica‐Like Endodontic Files: A Scoping Review of Current Evidence

## TL;DR

This review highlights the risks of counterfeit and replica endodontic files, showing they often have poor quality and unsafe performance, endangering patients and requiring stronger regulations.

## Contribution

The study provides a comprehensive evaluation of the mechanical and metallurgical risks of counterfeit and replica endodontic files through a scoping review of in vitro evidence.

## Key findings

- Counterfeit files show design flaws, surface defects, and altered metallurgy, leading to unsafe mechanical behavior.
- Replica-like files have inconsistent performance, with some matching originals but others being inferior in flexibility or torsional resistance.
- Quality control for these files is inconsistent, emphasizing the need for regulatory improvements and clinical validation.

## Abstract

This scoping review mapped and critically appraised laboratory evidence on counterfeit and replica‐like nickel–titanium endodontic files, evaluating design, metallurgical composition, surface finishing, and mechanical performance to clarify clinical and regulatory implications. Comprehensive searches of major databases and key endodontic journals identified 17 in vitro studies; no clinical studies were found. Counterfeit instruments consistently exhibited design irregularities, surface defects, and altered metallurgical properties that reduced cyclic fatigue resistance and produced unpredictable mechanical behaviour, posing significant patient‐safety concerns. Replica‐like instruments showed heterogeneous performance, with some matching or rarely exceeding original files in specific tests but others demonstrating inferior flexibility or torsional resistance. Quality‐control standards were inconsistent or lacking. These findings demonstrate that deviations in alloy processing, phase transformation, and surface finishing compromise mechanical reliability and highlight the urgent need for stronger regulatory oversight and clinical validation to safeguard practitioners and patients.

Counterfeit and replica‐like nickel‐titanium files have entered the dental market, often indistinguishable from authentic brands but differing in metallurgy, design, and performance. Laboratory evidence demonstrates that counterfeit instruments show poor manufacturing quality and unsafe mechanical behaviour, posing a significant risk of instrument fracture and treatment failure. Replica‐like files display variable properties, some comparable to originals and others inferior, highlighting the need for cautious selection and regulatory oversight.