(54 days)
The F I Series Dental Chairs with Operative Unit is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic/office environment and used by trained dentists and/or dental to thicials and assistants.
F1 Series Dental Chairs with Operative Units provide patient comfort and dentists' air and water supplies for dental instruments and procedures. Water pressure: 200400Kpa. Air pressure: 600800Kpa. The units can be powered from ~110/220/230V. The chair is motorized. The system is compatible with instruments from various manufacturers with standard fittings.
This document is a 510(k) summary for a dental operative unit, not an AI/ML device, therefore, the information requested about acceptance criteria, study details, and AI/ML specific metrics are not present in the provided text.
The document focuses on establishing substantial equivalence to an existing predicate device based on:
- Indications for Use: Both the F1 Series Dental Chairs with Operative Unit and the predicate Sirona Dental Systems C8+ are intended to "supply power to and serve as a base for dental devices and accessories" and include a dental chair for use in a dental clinic/office by trained personnel.
- Feature Comparisons: Key features like power supply (100/120/240 ac), components (chair, dentist instrument board, cuspidor, assistants board, dental light, footswitches), and compatibility with various dental instruments are stated as "SAME" or comparable to the predicate.
- Safety Standards: The F1 Series Dental Chairs with Operative Unit states compliance with "UL Standard for Safety, Medical Devices, UL 60601-1," while the predicate's safety standards are "Not specified" in the comparison table. However, the FDA's approval indicates satisfactory safety for the intended use.
Therefore, the table for acceptance criteria and device performance, and the detailed study information regarding AI/ML efficacy, cannot be extracted from this document. This document is a regulatory submission for a traditional medical device, not an AI/ML-powered one.
§ 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.