(126 days)
Sable Industries Premium Slow Speed Dental Handpieces & Accessories are indicated for use in general dentistry for cleaning and polishing of teeth.
A. Premium Slow Speed 20K Air Motor w/ Internal Air & Water:
The Sable Premium Slow Speed Air Motor is used in conjunction with accessories such as contra-angle and straight attachments that are manufactured in accordance with ISO 7785-2. This premium slow-speed air-driven motor is capable of running up to a speed of 20,000 RPM at 43.5 PSI (3 Bar). It does not require a separate coupler and interfaces with Midwest-type 4-hole tubing. The motor has an integrated locking mechanism for easy connection and removal of any attachment. The motor can deliver both chip air and water to assist with the removal of debris from the cutting area in the oral cavity when used in conjunction with an ISO designed attachment with internal air and water lines.
B. Slow Speed & Premium Slow Speed Heads (push button and switch latch)
The Sable Premium Slow Speed Heads are used in conjunction with attachments (Contra-angles and straight) and slow speed motors manufactured in accordance with -ISO-7785-2 and ISO 13294 respectively. These heads have an integrated locking mechanism for easy connection and removal of any attachment. These heads can be used with a variety of different latch burs conforming to the specifications of ISO 1797-1" +These heads are capable of running up to a speed of 40,000 RPM at 42 PSI (3 Bar) and have a 1:1 gear/drive ratio. These heads may be used with attachments capable of delivering both chip air and water when used in conjunction with an ISOdesigned air or electric motor with internal air and water.
C. Premium Slow Speed Contra-Angles (1:1 Fiber Optic and Non-Fiber Optic Ball Bearing w/ Internal Air & Water):
The Sable Premium Slow Speed Contra-Angles are used in conjunction with components such as slow speed heads and slow speed motors manufactured in accordance with ISO 7785-2-and ISO 13294, respectively. The fiber optic version produces 25,000 LUX for a shadow-less view of the oral cavity. These contraangles have an integrated locking mechanism for easy "snap-on" connection and removal from the motor. These contra-angles can be used with Sable premium slow speed heads which are attached / removed by a "quick-twist" locking mechanism on the contra Angle. These contra-angles are capable of running up to a speed of 40,000 RPM at 43.5 PSI (3 Bar) and have a 1:1 gear/drive ratio. These contra-angles deliver both chip air and water when used in conjunction with an ISO-designed air or electric motor with internal air and water.
D. Premium Slow Speed Straight Nosecones (1:1 Ball Bearing w/ Internal Air & Water):
The Sable Premium Slow Speed Straight Nosecones are used in conjunction with slow speed motors manufactured in accordance with ISO 13294 These nosecones have an integrated locking mechanism for easy connection and removal from the motor and can be used with a variety of different burs conforming to the specifications of ISO 1797-1. These nosecones are capable of running up to a speed of 40.000 RPM at 42 PSI (3 Bar) and have a 1:1 gear/drive ratio. These nosecones deliver both chip air and water when used in conjunction with an ISO-designed air or electric motor with internal air and water.
This document describes the 510(k) summary for Sable Industries' Premium Slow Speed Dental Handpieces & Accessories.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't specify numerical "acceptance criteria" in the format of a typical medical device study with specific performance metrics (e.g., accuracy, sensitivity, specificity) for an AI or diagnostic device. Instead, the device's "acceptance criteria" appear to be conformity with established international standards for dental handpieces and sterilization. The "reported device performance" is implicitly that the device meets these standards, thus demonstrating it is as safe and effective as predicate devices.
| Acceptance Criteria (Compliance to Standard) | Reported Device Performance (Implicitly Met) |
|---|---|
| ISO 13294 Dental Handpieces – Dental Air Motors | Conforms to standard |
| ISO 7785-2 Dental Handpieces – Part 2: Straight & Geared Angle Handpieces | Conforms to standard |
| ISO 9168 Dental Handpieces – Hose Connections | Conforms to standard |
| ISO 3964 Dental Handpieces – Coupling Dimensions | Conforms to standard |
| ISO 17665-1:2006 Sterilization of health care products – Moist heat – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | Conforms to standard |
| ISO 11134 Sterilization of health care products – Requirements for validation and routine control – Industrial moist heat sterilization | Conforms to standard |
| ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing | Conforms to standard |
2. Sample Size Used for the Test Set and Data Provenance
This submission is for a medical device (dental handpieces), not a software or AI-driven diagnostic device. Therefore, the concept of a "test set" and "data provenance" (country of origin, retrospective/prospective) as typically applied to AI studies is not applicable here. The evaluation is based on engineering design, materials, and mechanical performance tests to ensure compliance with the stated ISO standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for this type of device is established by compliance with international engineering and safety standards, not by expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
Not applicable. There is no diagnostic "test set" that requires adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a mechanical device, not an AI or diagnostic tool that involves human readers.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical dental handpiece, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this medical device is compliance with established international engineering, manufacturing, and safety standards (e.g., ISO 13294, ISO 7785-2, ISO 9168, ISO 3964, ISO 17665-1, ISO 11134, ISO 10993-1).
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI or machine learning algorithm. The design and manufacturing process would involve engineering specifications, testing of prototypes, and quality control of production units.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no training set for an AI algorithm, there's no ground truth established in that context. The design of the device is based on established engineering principles and adherence to the aforementioned ISO standards, which themselves represent an agreed-upon "ground truth" for safe and effective dental handpiece design and performance.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.