(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.
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Image /page/0/Picture/0 description: The image shows the logo for Summit Dental Systems. The logo consists of the letters SDS stacked on top of each other on the left side of the image. To the right of the letters is the text "SUMMIT DENTAL SYSTEMS" in a bold, sans-serif font. There are horizontal lines above and below the letters SDS.
4.V. 21st Avenue, Suite 141 • Ft. Lauderdale, Florida USA 33309 • (954) 733-4302 • (800) 275-3368 • FAX (954) 733-4303
510(K) Summary JAN 22 1997
Contact Person: Cesar Coral President
Date Prepared: September 24, 1996
SDS Model 1400 XL Deluxe Dental Delivery System Trade Name:
Common Name: Chair Mounted Dental Unit
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 svringe 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 components that make up this delivery system in many instances are generic to the dental industry and are made of the same materials utilized by other manufacturers that provide an equivalent product. These materials include poly vinyl compounds (PVC), polyurethane tubing, stainless steel, painted steel, anodized and plated alloy compounds, and ABS plastics. These manufacturers would include, but not be limited to, Forest Medical Products, Hillsboro, OR, Beaverstate Dental Inc., Tualatin, OR, Ampco Dental Equipment Company, Santa Maria, CA, and Marus Dental International, Bend, OR.
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The delivery system is designed as a dental chair mounted unit and mounts on a two inch steel post. The two inch post is accepted as a dental industry standard. The polyurethane air and water supply lines are connected in a floor mounted metal utility box. The utilities should be provided by contractors, and/or plumbers, that bring the utilities to the required space in compliance with all local codes. The air and water lines have both manual shut off valves and pneumatically controlled automatic shut valves. The pneumatic shut off valves are controlled by the master on/off toggle located on the control section of the delivery system. Also provided in the utility box for both the air and water are filter/regulator assemblies. Recommended air pressure is 80 PSI. Recommended water pressure is 40 PSI.
§ 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.