(65 days)
The 1400 XL Deluxe Dental Delivery System is designed to conveniently position the dentist's dynamic instruments for use during dental procedures.
The 1400 XL Deluxe Dental Delivery System is designed to conveniently position the dentist's dynamic instruments for use during dental procedures. The arm system the control head is affixed to consists of three pieces. The first section is a rigid arm that mounts on a two inch outside diameter post. Attached to the end of the rigid arm section is a flex arm section that allows for vertical positioning. The flex arm section contains a pneumatic brake that helps provide positive positioning. The third piece is a control mount that allows flexibility in the horizontal positions. The delivery system provides connections for three pneumatically operated instruments. The common instrument used is the dental handpiece. The unit provides automatic instrument selection by means of a three way pneumatic valve located in each instrument hanger assembly. The automatic selection takes place when a static air pressure signal is removed from the top of a diaphragm located in the handpiece control block. The actual activation of the instrument is initiated by pressing on a foot containing a three way pneumatic valve. The delivery system also provides an air and water syringe for use as the dental procedure may require. The air and water syringe has an autoclavable syringe tip. The control also houses a master on/off control. air volume adjustments for the pneumatic instruments, water coolant volume adjustments, flex arm brake toggle, and an air coolant volume adjustment. There is also a toggle valve located on the control that allows for water purging of the water coolant lines that supply the pneumatic instruments with water coolant. The air and water utilities are are supplied through polyurethane tubing housed in a flexible umbilical.
The provided text is a 510(k) summary for the SDS Model 1400 XL Deluxe Dental Delivery System. This document describes a dental delivery system and its components, not a device that uses AI or requires specific performance criteria measured by a study in the way requested.
Therefore, I cannot extract the information requested regarding acceptance criteria, device performance tables, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types. These concepts are relevant to the evaluation of diagnostic or AI-powered medical devices, which this dental delivery system is not.
The document describes the physical characteristics, function, and materials of a dental chair-mounted unit. It focuses on its design, connections for instruments, utility requirements, and comparison to generic components in the dental industry.
§ 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.