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Physiostar NFC denture teeth are intended to be used for complete and partial denture r nyslostar NF & dontare tooling and implant-supported dentures.

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I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Candulor USA, Incorporated, regarding their Physiostar NFC device, which is a preformed plastic denture tooth.

The letter confirms the FDA's determination of substantial equivalence for the device based on its intended use, but it does not detail any performance studies, acceptance criteria, or specific performance metrics of the device itself. It mainly focuses on regulatory aspects and compliance requirements.

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Direct Crown Natural 1 is intended for the fabrication of short and long term temporary crowns and bridges (up to 12 months) using the Direct Crown shell teeth.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental device called "Direct Crown Natural 1," which is a temporary crown and bridge resin.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not describe:

• Acceptance criteria and reported device performance (in a table or otherwise).
• Details of any study (sample size, data provenance, expert qualifications, ground truth establishment, MRMC studies, standalone performance, training set size).

The document is purely an FDA clearance notification, not a study report or clinical trial summary.

Therefore, I cannot provide the requested table or answer the specific questions about device performance studies based on the provided text.

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