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Bruxor™ is intended to protect teeth and reduce the damage caused by bruxing, or night time teeth grinding, and to prevent the noise associated with bruxing and grinding.

The Bruxor mouthguard consists of a single 'boil & bite' tray, fabricated from a thermoplastic resin, that fits over the upper dental arch.

The provided document is a 510(k) summary for the Bruxor™ mouthguard (K172452). It outlines the device description, intended use, and a comparison to a predicate device, but it does not contain a study that demonstrates device performance against specific acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions regarding sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present.

The "Nonclinical Testing" section (page 5) mentions that biocompatibility was established in accordance with ISO 10993 requirements and device material physical properties (melting point, density, melt flow rate) were evaluated. However, it explicitly states: "Biocompatibility and physical properties of the thermoplastic resin material were previously established through the reference device (K170825). Additional test reports were therefore not submitted as a part of this filing." This indicates that no new study specifically proving the Bruxor™ device's performance against acceptance criteria was submitted or detailed in this 510(k) summary.

The primary method used for clearance of the Bruxor™ device is through demonstrating substantial equivalence to a predicate device (Custom Comfort Nightguard Version 2, K091660) and a reference device (SnoreRx, K170825). The substantial equivalence argument relies on the technological features, materials, and intended use being similar to already cleared devices, rather than new performance studies on the Bruxor™ itself.

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