(84 days)
Laser-assisted Bleaching/Whitening of the teeth. Illumination purposes for the adjunctive use in caries detection and endodontic orifice location. Curing of all light sensitive bonding materials including: Pit and fissure sealants, composite restorations, endodontic composite cores, composite cements for porcelain facings and inlays, periodontal splint material, and prosthetic reline and repair material.
The Dental 200, 300, & 400 Laser Systems are an instrument used in the application of Dentistry. With a level of output power of up to 10.0 Watts on some models, and the selectable blue or green wavelengths, additional indications for use are warranted. The use of these dental laser devices are supported by a line of FiberFlex™ Fibers in sizes of; 200, 300, 400, & 600 microns. Cannulas specifically designed for use in Dentistry and as companion to the bare fibers. The primary energy output source is an Argon Ion laser head for delivery to the patient. The selectable laser wavelength colors of green (treat) and blue (cure). This system has similar timing features for interval, and duration. The Aiming Beam is a visible Red Diode @ 630-680nm.
This document is a 510(k) premarket notification for the Dental 200, Dental 300, and Dental 400 Argon Laser Systems. It establishes substantial equivalence by comparing the submitted devices to predicate devices. As such, it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.
The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, not on proving new performance claims against defined criteria through a study.
Therefore, I cannot provide the requested information from this document. Here's why:
- Acceptance criteria and reported device performance: This document describes the functional characteristics of the device and compares them to predicate devices, but it does not specify quantitative acceptance criteria (e.g., "device must achieve X % accuracy") or report performance data against such criteria.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth for training set: These are all elements typically found in a clinical study report or performance validation report, which are not part of this 510(k) summary. The summary focuses on design and functional similarity to predicates.
In a 510(k) submission, the "study" that proves the device meets acceptance criteria is often a bench testing comparison to a predicate device or analysis of existing literature about the predicate device's performance, rather than a de novo clinical trial with specific performance endpoints. The "acceptance criteria" are implied by the performance of the predicate device.
§ 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.