DENTSPLY CAVITRON SPS SCALER SYSTEM

K970123 · Dentsply Intl. · ELC · Apr 11, 1997 · Dental

Device Facts

• Record ID: K970123
• Device Name: DENTSPLY CAVITRON SPS SCALER SYSTEM
• Applicant: Dentsply Intl.
• Product Code: ELC · Dental
• Decision Date: Apr 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SPS SCALER SYSTEM is designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry. This SPS SCALER SYSTEM is used with scaling tips and a fine warm water spray for debriding light to heavy calculus and plaque deposits from tooth and root surfaces.

Device Story

Portable ultrasonic scaler for dental prophylaxis and periodontal treatment. Device converts AC electrical current into high-frequency (30 kHz) electro-mechanical vibrations via a transducer. System includes electronic driving system with two control loops: automatic frequency control for optimal operation and automatic stroke control (Automatic Gain Control) to maintain tip stroke under load. Foot pedal activates ultrasonic tip and irrigation (warm water spray). Water acts as coolant and cleaning agent. Used by dental professionals in clinical settings. Enhancements include low-power mode for periodontal applications, foot-switch activated boost mode, and improved base unit material resistant to disinfectants. Device removes calculus and plaque, improving patient comfort through controlled stroke and irrigation.

Clinical Evidence

Bench testing only. In-house testing confirmed performance within specifications. SEM analysis showed no significant qualitative difference in tooth surface effects compared to the predicate device. EMC testing conducted by Underwriters' Laboratory with positive results.

Technological Characteristics

Ultrasonic scaler; 30 kHz nominal operating frequency. Features: automatic frequency control, automatic stroke control (Automatic Gain Control), foot-switch activated boost mode. Power: AC electrical input. Cooling: integrated water irrigation system. Base unit material: disinfectant-resistant polymer. Connectivity: standalone. Sterilization: compatible with common wipe disinfectants.

Indications for Use

Indicated for general prophylaxis, periodontal treatments, and operative dentistry procedures requiring debridement of light to heavy calculus and plaque deposits from tooth and root surfaces.

Regulatory Classification

Identification

An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Predicate Devices

• CAVITRON® MODEL 3000™ ULTRASONIC SCALER (K864996)

Submission Summary (Full Text)

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APR 11 1997
510(k) SUMMARY
Page 1 of 2

DENSPLY

NAME & ADDRESS: K970123
DENTSPLY International
570 West College Avenue
P.O. Box 872
York, PA 17405-0872
[phone]
Fax [phone]
P. J. Lehn Telefax [phone]

CONTACT: P. Jeffery Lehn
DATE PREPARED: January 10, 1997

TRADE NAME: DENTSPLY® CAVITRON® SPS SCALER SYSTEM

CLASSIFICATION NAME: Ultrasonic Scaler 21 CFR, 872.4850

PREDICATE DEVICE: CAVITRON® MODEL 3000™ ULTRASONIC SCALER K864996

DESCRIPTION: The SPS SCALER is a portable stand alone ultrasonic scaler. It operates with a fine, warm water spray, easily and effectively removing stubborn calculus and stains both supragingivally and subgingivally.

The SPS SCALER plugs into an ordinary electrical outlet and converts the 60 cycle AC house current into high frequency electro-mechanical vibrations. It consists of two parts: an electro-mechanical transducer and an electronic driving system. The electronic system incorporates two control loops: the first loop provides automatic frequency control driving each transducer at it's optimum operating frequency (nominally 30 kHz), while the second loop provides automatic stroke control to compensate for different transducer loading conditions. The SPS SCALER produces 30,000 microscopically small strokes each second at the transducer's tip. This, combined with acoustic effects of the coolant water, produces a synergistic action that sweeps away the heaviest calculus deposits while providing exceptional operator and patient comfort.

While the controls for the power and water flow of the SPS SCALER SYSTEM are located on the base unit, the on/off control used during operation is located on the foot pedal. When the foot pedal is pressed, the ultrasonic tip is activated and irrigation starts. The water from the irrigation system acts as both a cleaner and a coolant.

INTENDED USE: The SPS SCALER SYSTEM is designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry. This SPS SCALER SYSTEM is used with scaling tips and a fine warm water spray for debriding light to heavy calculus and plaque deposits from tooth and root surfaces.

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510(k) SUMMARY (cont'd.)
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# DENTSPLY® CAVITRON® SPS SCALER SYSTEM

TECHNOLOGICAL CHARACTERISTICS: The SPS SCALER SYSTEM is substantially equivalent to the predicate device, DENTSPLY's Cavitron Model 3000® Ultrasonic Scaler (K864996), in intended use, as well as in design and construction. The basic technology, primary energy source, maximum electrical input power, maximum mechanical output energy, and base unit material are identical to the predicate device.

The SPS SCALER SYSTEM has the following enhancements: 1) a low power capability providing lower tip strokes than previously obtainable for periodontal applications and greater patient comfort; 2) a foot switch activated boost power mode which, when enabled, applies increased power to the handpiece; 3) a limited Automatic Gain Control circuit which automatically increases insert drive power, maintaining tip stroke under load; and 4) a smooth or appropriately textured, white base unit capable of withstanding common wipe disinfectants without discoloring or deteriorating.

The SPS SCALER meets DENTSPLY specifications. Underwriters' Laboratory conducted EMC testing on the SPS SCALER with positive results.

Results of in-house testing indicated that the SPS SCALER SYSTEM performed within stated specifications and was found to be as effective as the predicate device.

Results of SEM Analysis indicated that no significant qualitative difference was observed on the teeth following the use of the SPS SCALER SYSTEM compared to the predicate device.

We believe that the performance data and the testing reported above demonstrate the safety and effectiveness of the SPS SCALER SYSTEM for its intended use.

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