(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.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Sable Industries FEB 2 3 2009 Premium Slow Speed Dental Handpieces & Accessories
510(k) Summary Page 1 of 4
I. Submitter Information
510(k) Owner:
Sable Industries, Inc. 100 Campbell Avenue, Suite 5 Kitchener, Ontario N2H 4X8 Canada Establishment Registration: 3002105090
Jacob Jagt - QA Manager
(519) 579-9323 (office) (519) 579-9324 (fax)
Manufacturer Contact Person:
United States Agent / U.S. Consultant:
GlobalReg Compliance Associates, Inc. 16576 W. 53rd Way Golden, CO 80403 (303) 956-8595 (direct) (303) 828-0835 (fax) Email: info@globalregcompliance.com
Date Summary Prepared:
October 6, 2008
II. Name of Device
- Trade Name: Premium Slow Speed Dental Handpieces & Accessories .
- Common Name: Air-Powered Dental Handpieces & Gear-Driven Attachments
- Classification Name: Dental Handpiece & Accessories
III. Predicate Devices
| Subject Device | Predicate Device(s) |
|---|---|
| Premium Slow Speed 20K Air Motorw/ Internal Air & Water (p/n 1610101) | Bien Air Low Speed Motors(K983183) |
| Slow Speed & Premium Slow Speed HeadsBall Bearing Switch Latch(p/n 1610801) | Bien Air Straight and Contra-Angle Handpieces (K983183) |
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Sable Industries Premium Slow Speed Dental Handpieces & Accessories
510(k) Summary Page 2 of 4
| Subject Device | Predicate Device(s) |
|---|---|
| Slow Speed & Premium Slow Speed HeadsBall Bearing Push Button(p/n's 1610802, 1600411, 1600508) | Bien Air Straight and Contra-Angle Handpieces (K983183) |
| Premium Slow Speed Contra-Angles1:1 Fiber Optic Ball Bearing w/ Internal Air& Water (p/n 1610299) | Bien Air Straight and Contra-Angle Handpieces (K983183) |
| Premium Slow Speed Contra-Angles1:1 Ball Bearing w/ Internal Air & Water(p/n 1610201) | Bien Air Straight and Contra-Angle Handpieces (K983183) |
| Premium Slow Speed Straight Nosecones1:1 Ball Bearing w/ Internal Air & Water(p/n 1610301) | Bien Air Straight and Contra-Angle Handpieces (K983183) |
IV. Device Description & Technological Characteristics
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.
Slow Speed & Premium Slow Speed Heads (push button and switch latch) B.
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.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Sable Industries Premium Slow Speed Dental Handpieces & Accessories
510(k) Summary Page 3 of 4
-
Premium Slow Speed Contra-Angles (1:1 Fiber Optic and Non-Fiber Optic C. 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.
V. Intended Use
Sable Industries Premium Slow Speed Dental Handpieces & Accessories are indicated for use in general dentistry for cleaning and polishing of teeth.
Non-Clinical Performance/Safety Data VI.
The performance and safety of the Sable Industries Premium Slow Speed Dental Handpieces & Accessories are based upon conformity with applicable aspects of the following standards:
- ISO 13294 Dental Handpieces Dental Air Motors ◆
- ISO 7785-2 Dental Handpieces -- Part 2: Straight & Geared Angle Handpieces
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Sable Industries Premium Slow Speed Dental Handpieces & Accessories
510(k) Summary Page 4 of 4
- ISO 9168 Dental Handpieces -- Hose Connections .
- ISO 3964 Dental Handpieces Coupling Dimensions
- ISO 17665-1:2006 Sterilization of health care products -- Moist . heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 11134 Sterilization of health care products Requirements . for validation and routine control -- Industrial moist heat sterilization
- ISO 10993-1 Biological Evaluation of Medical Devices Part-1: . Evaluation and Testing
Conformity with the above standards demonstrates that the Sable Industries Premium Slow Speed Dental Handpieces & Accessories are as safe, as effective, and perform as well as or better than the predicate devices.
END OF 510(K) SUMMARY
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
FEB 2 3 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sable Industries, Incorporated C/o Mr. Kevin Randall President GlobalReg Compliance Associates, Incorporated 16576 West 53rd Way Golden, Colorado 80403
Rc: K083101
Trade/Device Name: Premium Slow Speed Dental Handpieces and Accessories Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB, EGS Dated: January 27, 2009 Received: February 20, 2009
Dear Mr. Randall:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -- Mr. Randall
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Kunes
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): KO831D|
Device Name:
Premium Slow Speed Dental Handpieces & Accessories
Indications For Use:
Sable Industries Premium Slow Speed Dental Handpieces & Accessories are indicated for use in general dentistry for cleaning and polishing of teeth.
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED-
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use Prescription Use OR (Optional Format 1-2-96) 0000 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices xvi Ko83 O 510(k) Number: _
§ 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.