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510(k) Data Aggregation

    K Number
    K083101
    Device Name
    PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES
    Manufacturer
    SABLE INDUSTRIES, INC.
    Date Cleared
    2009-02-23

    (126 days)

    Product Code
    EFB, EGS
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SABLE INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sable Industries Premium Slow Speed Dental Handpieces & Accessories are indicated for use in general dentistry for cleaning and polishing of teeth.
    Device Description
    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.
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    K Number
    K072554
    Device Name
    ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES
    Manufacturer
    SABLE INDUSTRIES, INC.
    Date Cleared
    2007-11-14

    (65 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SABLE INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sable Industries Fiber Optic High Speed Dental Handpieces & Accessories are indicated for the preparation of dental cavities for restorations, such as fillings.
    Device Description
    The Access™ L & KL and RotaMax™ L & KL Fiber Optic High Speed Dental Handpieces and Accessories are indicated for use in the preparation of dental cavities for restorations, such as fillings. These handpicces arc a scries of fiber optic high speed, air-driven turbine handpieces for use with standard size burs in accordance with ISO 1797. The technological characteristics and form/fit/function of the Access™ L & KL and RotaMax™ L & KL handpieces, respectively, are substantially equivalent to the Bien-Air Prestige L & LK Turbine Handpieces (FDA-cleared via K983183) and the Bora L & LK Turbine Handpieces (FDA-cleared via K983183). The Access™4 series have a stainless steel ball bearing turbine with rotational speeds of up to 335,000 rpm and a smaller head as compared to the RotaMaxTM models. The Access™ is available for use with a Sable 6 Hole, 360° Swivel Quick Connect Coupler or Multiflex™ Coupler. The handpiece also contains a triple spray cooling system. The three air and water ports are located within the detachable diffuser. The diffuser is replaceable and is easily removed for cleaning. The Access™ incorporates an anti-retraction valve within the handle. The handpiece is autoclavable to 135° C. The Access™ has a patented nonheating, push button chuck bur-changing mechanism. The dual glass optics consist of a single block of optic rods. The glass rods are angled to help reduce shadows on the tooth. The fiber-optic light unit is fully interchangeable. The RotaMax™ series have a ball bearing turbine with rotational speeds of up to 310,000 rpm and a larger head as compared to the Access™ models. The RotaMax™ is available for use with a Sable 6 Hole, 360° Swivel Quick Connect Coupler or Multiflex™ Coupler. The handpiece also contains a triple sprav cooling system. The three air and water ports are located within the detachable diffuser. The diffuser is replaceable and is easily removed for cleaning. The RotaMax™ incorporates an anti-retraction valve within the handle. The handpiece is autoclavable to 135° C. The RotaMax™ also has a patented nonheating, push button chuck bur-changing mechanism. The dual glass optics consist of a single block of optic rods. The glass rods are angled to help reduce shadows on the tooth. The fiber-optic light is fully interchangeable. The electronic fiber optic control board available for use with the Access™ and RotaMax™ series handpieces is for one or two handpieces and supplies an adjustable power output ranging from 2 - 3.5 volts. The control board has an adjustable illumination time delay ranging from 0.5 - 4.5 seconds for each handpiece. A range of air hoses are available for use with the Access™ and RotaMax™ series handpieces. The connectors for these hoses meet the criteria either for Type B or C per ISO 9168, and therefore have five outlets (to accommodate drive-air & exhaust, fiber optic, spray-air, and irrigation) or four outlets plus electrical contacts (to accommodate drive-air & exhaust, fiber optic power supply, sprayair, and irrigation). The air hoses arc straight and come in various colors. KaVo Spray (preamendments device) or other FDA-cleared lubricants may be used to lubricate the Access™ L & KL and RotaMax™ L & KL Fiber Optic High Speed Dental Handpieces.
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