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To be used for endodontic and general dentistry applications.

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The provided document is a 510(k) premarket notification letter from the FDA regarding a Portable Dental System (K130693). This type of document confirms that a device is substantially equivalent to a legally marketed predicate device, a process that typically does not involve new clinical studies to prove effectiveness against specific acceptance criteria in the same way a new drug or novel high-risk device might.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. Specifically:

• It does not list any acceptance criteria.
• It does not describe any specific study conducted by the manufacturer to demonstrate the device's performance against such criteria.
• It does not mention sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The 510(k) pathway relies on demonstrating substantial equivalence to pre-existing, legally marketed devices. This often involves performance data demonstrating safety and effectiveness similar to the predicate device, but not necessarily against newly established, quantitatively defined acceptance criteria that would require a detailed study as outlined in your request. The "Indications for Use Statement" simply states the intended clinical applications: "To be used for endodontic and general dentistry applications."

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