(98 days)
The gumEase® dental mouthpiece provides temporary relief from oral discomfort resulting from dental work, brace pain, denture irritation, post surgical pain or minor oral trauma.
The gumEase® dental mouth piece is manufactured from biocompatible plastic tubing that is filled with a NaCl solution.
The provided text describes a 510(k) submission for the "gumEase® dental mouthpiece." This submission focuses on establishing substantial equivalence to predicate devices based on safety and effectiveness, rather than reporting on a clinical study with acceptance criteria and performance metrics for a novel diagnostic or treatment device.
Therefore, the requested information regarding acceptance criteria, device performance, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document.
The document states that substantial equivalence was established by the "principle of similarity of the Intended Use, Biocompatibility operation, device design and Simmanty of the predicate devices." It also mentions "Biocompatibility testing was performed in accordance with the ISO 1993 guidelines and all test results confirmed the device is biocompatible."
Essentially, this is a regulatory clearance for a low-risk device based on its similarity to existing cleared devices, not a study evaluating and quantifying its performance against specific clinical efficacy or diagnostic accuracy criteria.
§ 872.5550 Teething ring.
(a)
Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.(b)(1)
Classification. Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.(2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.