(87 days)
Not Found
No
The description focuses on electro-mechanical vibrations and control loops for frequency and stroke, which are traditional engineering control systems, not AI/ML. There is no mention of AI, ML, or related concepts like image processing, training data, or performance metrics typically associated with AI/ML devices.
Yes
The device is used for debriding calculus and plaque deposits for prophylaxis and periodontal treatments, which are therapeutic medical purposes.
No
The device is described as an ultrasonic scaler used for debriding calculus and plaque, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines hardware components including an electro-mechanical transducer, an electronic driving system, a base unit, and a foot pedal, and describes its operation involving electrical current and mechanical vibrations.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general prophylaxis and periodontal treatments and other areas of operative dentistry," specifically for "debriding light to heavy calculus and plaque deposits from tooth and root surfaces." This describes a procedure performed directly on a patient's teeth, not a test performed on a sample taken from the body.
- Device Description: The description details an ultrasonic scaler that uses mechanical vibrations and water spray to remove deposits from teeth. This is a physical intervention, not a diagnostic test.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition. The device's function is purely therapeutic/prophylactic.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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 .
Product codes
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Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth and root surfaces.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4850 Ultrasonic scaler.
(a)
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.(b)
Classification. Class II.
0
APR 11 1997
510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
DENTSPLY International
K97012
570 West College Avenue P.O. Box 872 York, PA 17405-0872 7171 845-7511 ax (717) 854-2343 (717) 849-4343 P. J. Lehn Telefax
P. Jeffery Lehn CONTACT :
DATE PREPARED:
January 10, 1997
DENTSPLY® CAVITRON® SPS SCALER SYSTEM TRADE NAME:
21 CFR, 872.4850 CLASSIFICATION NAME: Ultrasonic Scaler
CAVITRON® MODEL 3000™ ULTRASONIC SCALER K864996 PREDICATE DEVICE:
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.)
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.
SPS SCALER meets DENTSPLY specifications. Underwriters' Laboratory The 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.