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The OrthoSlenderizer is intended for use as a method of achieving interproximal enamel reduction of teeth using a reciprocal movement.

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The provided text is an FDA 510(k) clearance letter for a device called "OrthoSlenderizer." It primarily addresses regulatory approval and does not contain information on acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on:

• Device Name: OrthoSlenderizer
• Regulation Number/Name: 21 CFR 872.4200, Dental Handpiece and Accessories
• Regulatory Class: I
• Product Code: EFB
• FDA Determination: Substantially equivalent to legally marketed predicate devices.
• Intended Use: "as a method of achieving interproximal enamel reduction of teeth using a reciprocal movement."

To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE) or the actual study report submitted with the 510(k) application.

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