(376 days)
Pulpotomy Filling material such as gutta percha or resin bakelite removal as adjunct treatment during root canal retreatment
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental laser (LOKKI DT Laser and Accessories). This document does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request to describe these elements based on the given text.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.