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The E-CUBE is indicated for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills(Gates-Glidden).

The E-CUBE is an AC-powered device that includes a hand-held motor and controller for regulation of speed and direction of rotation or a contra-angle attachment for dental implant surgery.

The provided document describes a 510(k) summary for the Saeshin E-CUBE, a dental handpiece. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, design, and adherence to safety standards.

However, the document does not contain any information regarding specific acceptance criteria for device performance, nor details of a study that proves the device meets such criteria in terms of clinical performance or accuracy.

Instead, the document highlights:

• Substantial Equivalence: The E-CUBE is deemed substantially equivalent to predicate devices (X-Smart Easy, K092614, and STRONG Implant Handpiece, K092412) in terms of intended use, materials, design, and use concept.
• Biocompatibility Testing: Biocompatibility of patient contact parts was demonstrated through cytotoxicity, sensitization, and irritation testing according to ISO 10993-1.
• Safety Standards: The device conforms to IEC 60601-1 (Medical electric equipment, Part 1: General requirements for safety) and IEC 60601-1-2 (electromagnetic compatibility).

Therefore, I cannot provide the requested table or detailed study information as it is not present in the provided text. The document focuses on regulatory compliance and equivalence to established devices rather than reporting on a specific performance study with defined acceptance criteria and clinical outcomes.

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