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Intended for Use as a long-term resilient lining material for removable dentures, and to reline, repair, clasp or rebase dentures.

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The provided document is a 510(k) premarket notification letter from the FDA for a dental device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the given input. The document is essentially a clearance letter, confirming that the device is substantially equivalent to legally marketed predicate devices, not a detailed study report.

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Intended for Use as an aligning bracket for removable dentures, and to aid in securing dentures.

The BITEM LOCK product is a thermo-adjustable alignment bracket with the same use as the predicate device. The only difference is the predicate device is Made from metal and this device is a thermo-adjustable material. The base materials for the BITEM LOCK include a methacrylate liquid, a phthalate plasticizer, an EGDMA cross linker and polymer powder. They are ready made for clinical application.

This document, an FDA 510(k) Summary for the BITEM LOCK orthodontic appliance, does not contain information related to acceptance criteria, a study proving device performance against such criteria, or any details about software algorithm performance.

The provided text focuses on:

• Device identification: Trade name, classification, submitter, and contact information.
• Predicate device comparison: Highlighting the BITEM LOCK's similarity in intended use and application to the predicate device (K900678 Myloc System Winder Research). The key difference noted is the material (thermo-adjustable vs. metal) and method of securing it.
• Intended use: Clearly stating its application as an alignment bracket for removable dentures and to aid in securing dentures.
• FDA determination: A letter from the FDA confirming substantial equivalence to a legally marketed predicate device, allowing the device to be marketed.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or MCRM/standalone study details because this content is not present in the provided text. The device described is a physical orthodontic appliance, not a software or AI-based medical device.

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