(65 days)
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No
The description details a purely mechanical and pneumatic dental delivery system with no mention of computational or learning capabilities.
No
The device is a delivery system for dental instruments and does not directly treat or diagnose a medical condition. Its purpose is to position instruments for use during dental procedures.
No
The device is described as a system for positioning dental instruments and providing connections for air and water, not for diagnosing conditions.
No
The device description clearly details a physical, mechanical, and pneumatic system with hardware components like arms, valves, tubing, and a foot control. It does not mention any software as a primary or even secondary component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "conveniently position the dentist's dynamic instruments for use during dental procedures." This describes a device used during a medical procedure on a patient, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a system for holding and controlling dental instruments like handpieces and syringes. It focuses on the mechanical and pneumatic aspects of delivering air and water to these instruments. There is no mention of analyzing biological samples or providing diagnostic results.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
- Measuring analytes
Therefore, the 1400 XL Deluxe Dental Delivery System is a dental instrument delivery system used in a clinical setting, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 1400 XL Deluxe Dental Delivery System is designed to conveniently position the dentist's dynamic instruments for use during dental procedures.
Product codes
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Device Description
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.
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
dentist's
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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.
1
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.