(107 days)
The A-dec 200 Dental System and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
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This document is an FDA 510(k) clearance letter for the A-dec 200 Dental System, which is a dental operative unit and accessories. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it's a clearance letter and not a study report. The device is classified as Class I, meaning it has the lowest risk and generally requires less stringent premarket review compared to Class II or III devices.
Therefore, I cannot provide the requested information based on the provided text. The document primarily focuses on:
- Device Clearance: The FDA's determination that the A-dec 200 Dental System is substantially equivalent to legally marketed predicate devices.
- Regulatory Compliance: Reminders about general controls, specific regulations (CFR Parts 800-898), and reporting requirements.
- Indications for Use: A brief description of what the device is intended for.
The requested details such as acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information are typically found in a clinical study report or a design validation report, which are not part of this 510(k) clearance letter.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.