(62 days)
No
The device description focuses on mechanical and electrical components and functions (ultrasonic vibration, power generation, irrigation control) without mentioning any computational analysis, learning, or adaptive capabilities typically associated with AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The device is intended for dental treatments (Scaling, Periodontics, and Endodontics) which are therapeutic procedures focused on the preservation and treatment of soft and hard tissues in the mouth.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to provide overall prophylaxis and preservation of soft and hard tissue during the 3 standard dental treatments; Scaling, Periodontics, and Endodontics." This describes a therapeutic, preventative, or operational function, not a diagnostic one. There is no mention of the device identifying or detecting any disease or condition.
No
The device description clearly outlines multiple hardware components including a handpiece, control panel case, footswitch, cables, and internal electronics for generating ultrasonic power. It is a physical device with software controlling its functions, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "overall prophylaxis and preservation of soft and hard tissue during the 3 standard dental treatments; Scaling, Periodontics, and Endodontics." This describes a therapeutic and procedural use within the mouth, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details an ultrasonic scaler that uses mechanical vibration and cavitation to perform dental procedures. It does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or methods for detecting or measuring substances in biological samples, which are hallmarks of IVD devices.
Therefore, the SUPRASSON P-Max and SUPRASSON P5 are dental devices used for treatment, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The SUPRASSON P-Max and SUPRASSON P5 are intended to provide overall prophylaxis and preservation of soft and hard tissue during the 3 standard dental treatments; Scaling, Periodontics, and Endodontics.
Product codes
Not Found
Device Description
The SUPRASSON P5 Booster ultrasonic scaler consists of three primary components: the scaling instrument (PAM) "handpiece", the control panel case, and the footswitch.
The scaling instrument (PAM) "handpiece" is held in the physician's hand, but can also be stored in the holder located onto the case. The handpiece is connected to the control panel case via a fixed electrical cable connection. Tips are mounted by means of a tip wrench at the extremity of the handpiece. All SUPPRASON P5 Booster tips vibrate in a single plane (vibration from front to rear and along the tip axis) via piezoelectric ultrasonic power. This rectilinear motion provides a more accurate and more comfortable approach to the tooth and gum. The enamel and cement are protected from unnecessary lateral impacts.
The SUPRASSON P5 Booster, similar tc its predicate device, SUPRASSON P-MAX (K942139), operates from the action of cavitation, following the propagation of ultrasounds in a frequency spectrum comprised between 27 and 33 kHz and a mechanical effect following vibration of the tips mixing with water within a range of maximum amplitudes varving Irom 20 to 310 μm.
The portable plastic control panel case includes all control and ultrasonic power generation functions. A visible light diode informs the user when the device is in enable mode; it also serves as an indicator for the power regulation potentiometer knob. The power settings can be varied from 1-14, dependent upon the clinical application.
Housed in the portable case, internal electronics generate electrical signals at the ultrasound frequency in order for the tip screwed at the extremity of the handpiece to vibrate. Irrigation is provided by a water line manually controlled by tap knob which adjusts the spray at the tip of the handpiece, and is located on the flat side of the control panel case.
Connections to the case are all shorter than 3 m:
- the AC mains cable, 3 conductors, fixed, unshielded;
- the PAM cable, 3 conductors, fixed, unshielded;
- the footswitch cable, 2 conductors, fixed, unshielded.
The footswitch pedal has two functions. Pressure on the pedal activates/deactivates piezoelectric ultrasonic power triggering, and enables/disables the flowswitch, located inside the control panel case, for irrigation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician's hand
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
AY 2 3 1996
9. SMDA Summary of Safety and Effectiveness - "510(k) Summary"
- A. Submitter Information
SATELEC Z.I. du Phare, BP 216 Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE
Telephone: 011-33-56-34-063-07
Contact Person: Pascal Dupeyron Regulatory Affairs
Date Prepared: March 20 , 1996
- B. Device Identification
Common/Usual Name Proprietary Name:
Piezoelectric Ultrasonic Scaling Generator SUPRASSON P5 Booster
- C. Identification of Predicate Device(s)
The SUPRASSON P5 Booster is substantially equivalent to its predicate device. SUPRASSON P-MAX (K942139), previously cleared and currently marketed.
D. Device Description
The SUPRASSON P5 Booster ultrasonic scaler consists of three primary components: the scaling instrument (PAM) "handpiece", the control panel case, and the footswitch.
The scaling instrument (PAM) "handpiece" is held in the physician's hand, but can also be stored in the holder located onto the case. The handpiece is connected to the control panel case via a fixed electrical cable connection. Tips are mounted by means of a tip wrench at the extremity of the handpiece. All SUPPRASON P5 Booster tips vibrate in a single plane (vibration from front to rear and along the tip axis) via piezoelectric ultrasonic power. This rectilinear motion provides a more accurate and more comfortable approach to the tooth and gum. The enamel and cement are protected from unnecessary lateral impacts.
The SUPRASSON P5 Booster, similar tc its predicate device, SUPRASSON P-MAX (K942139), operates from the action of cavitation, following the propagation of ultrasounds in a frequency spectrum comprised between 27 and 33 kHz and a mechanical effect following vibration of the tips mixing with water within a range of maximum amplitudes varving Irom 20 to 310 μm.
1
The portable plastic control panel case includes all control and ultrasonic power generation functions. A visible light diode informs the user when the device is in enable mode; it also serves as an indicator for the power regulation potentiometer knob. The power settings can be varied from 1-14, dependent upon the clinical application.
Housed in the portable case, internal electronics generate electrical signals at the ultrasound frequency in order for the tip screwed at the extremity of the handpiece to vibrate. Irrigation is provided by a water line manually controlled by tap knob which adjusts the spray at the tip of the handpiece, and is located on the flat side of the control panel case.
Connections to the case are all shorter than 3 m:
- · the AC mains cable, 3 conductors, fixed, unshielded;
- · the PAM cable, 3 conductors, fixed, unshielded;
- · the footswitch cable, 2 conductors, fixed, unshielded.
pedal has two functions. Pressure on the pedal The footswitch activates/deactivates piezoelectric ultrasonic power triggering, and enables/disables the flowswitch, located inside the control panel case, for irrigation.
E. Substantial Equivalence
The technical characteristics are almost identical to those of the Satelec SUPRASSON P-Refer to Table A for a comparison with the predicate device. Differences that exist Max. between these devices relating to technical specifications, materials, physical appearance, and control systems do not affect the relative safety or effectiveness of the SUPRASSON P5 Booster relative to its predicate.
The SUPRASSON P-Max and SUPRASSON P5 are intended to provide overall prophylaxis and preservation of soft and hard tissue during the 3 standard dental treatments; Scaling, Periodontics, and Endodontics.