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The INTRA Lux Head 3 LDSY reciprocating dental handpiece attachment is intended for use in root canal preparations using hand-held endodontic files.

The INTRA Lux Head 3 LDSY reciprocating dental handpiece attachment is for use by a trained professional in general dentistry. The device is attached to air-powered or electrical handpieces. The reciprocating dental handpiece attachment is re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.

The provided text is related to a 510(k) submission for a dental handpiece attachment. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence based on design, application, and function compared to existing legally marketed devices, rather than presenting a performance study with defined acceptance criteria.

Therefore, I cannot provide the requested table and details because the information is not present in the given text. The document is primarily a regulatory submission for premarket notification, not a report detailing a clinical or technical performance study.

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