(104 days)
ALOCLAIR™ ORAL SPRAY is indicated for pain relief in all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers and abrasions caused by braces and ill fitting dentures and diffused aphthous ulcers. Aloclair Gel forms a protective film that covers lesions to provide rapid pain relief, and avoid further imitation.
ALOCLAIR™ ORAL SPRAY is indicated for all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers caused by braces and ill fitting dentures and diffused aphthous ulcers.
ALOCLAIR™ ORAL SPRAY is a viscous spray formulation, which is presented for over-thecounter use premixed in various sizes. This combination of substances, when rinsed around the mouth, forms a protective layer over the oral mucosa.
This document is a 510(k) summary for the ALOCLAIR™ ORAL SPRAY. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain a study that establishes acceptance criteria or reports detailed device performance against such criteria.
The document states:
- "Extensive functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL SPRAY. All results are satisfactory."
This is a general statement and does not provide the specific details required to answer your request. Therefore, I cannot provide the requested information based on the input text.
The requested information (acceptance criteria, specific study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information) is not present in the provided 510(k) summary.
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