(270 days)
- Curing of all light cured bonding materials.
- Curing of pit and fissure sealants (unfilled resins).
- Curing for all classes of composite restorations (filled resins).
- Curing for endodontic composite cores.
- Curing composite cements for porcelain facings and inlays.
- Curing of light activated periodontal splint material.
- Curing of light activated prosthetic reline and repair material.
- Curing used in the fabrication of laboratory indirect light activated restorations and provisional restorations.
- Illumination purposes for the adjunctive use in caries detection.
- Illumination purposes for the adjunctive use for endodontic orifice location.
- Light activation for bleaching materials for teeth whitening.
Not Found
This is a 510(k) clearance letter for the Arago II device, a light curing unit. This document does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
This means the device was cleared based on a demonstration of substantial equivalence to a previously legally marketed predicate device, not on meeting specific performance acceptance criteria via a new study. The 510(k) process typically involves showing that a new device is as safe and effective as a predicate through various comparisons, which may include performance data, but it does not necessarily require a separate, new clinical study with pre-defined acceptance criteria if substantial equivalence can be demonstrated through other means (e.g., comparison of technical characteristics, non-clinical tests).
Therefore, I cannot provide the requested information from the provided 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.