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The SONICflex 2003 and SONICflex Lux 2003 L with Instrument Tips are air-powered scalers intended for use in following areas:

• · Tooth scaling and cleaning · Scaling:
  • · Tooth neck and subgingival treatment
  • · Root planning
  • · Initial therapy
  • · Implant maintenance
  • · Canal preparation and cleaning
  • · Micro retro surgery
  • · Inlay / onlay condensation
  • · Fissure cleaning
  • · Minimal invasive cavity cleaning
• · Endodonties:
  · Periodontics:
• · Prosthesis:

The SONICflex 2003 and SONICflex Lux 2003 L with Instrument Tips are air-powered scalers for use by qualified dental practitioners in the four conventional dental applications of scaling, periodontics, endodontics and prosthesis.

The SONICHex 2003 / SONICJlex Lux 2003 L. & Instrument Tips consist of a handpiece, instrument tips, quick-action coupling and accessories for changing and cleaning the instrument tips. The handpieces are attached over a coupling and a hose to a dental operative unit. The power delivered to the handpiece is adjusted via a control ring located on the handpiece. The only difference between the SONICflex 2003 and the SONICJlex Lux 2003 L scaler is that the SONICflex Lux 2003 1. has an integrated fiber optic. A variety of tips are available for specific dental applications and for reaching different areas of the mouth. The devices can be sterilized by the steam autoclave method.

The provided text is a 510(k) summary for a dental ultrasonic scaler, the SONICflex 2003 and SONICflex Lux 2003 L. This type of regulatory submission is focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies as one might find for a novel, high-risk device or an AI/ML-enabled device.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Here's why and what the document does indicate:

• Substantial Equivalence: The core of this 510(k) is to show that the new device (SONICflex 2003 series) is "substantially equivalent in design, application and function" to a legally marketed predicate device (Sirona Dental Systems GmbH, SIROAIR L Air Scaler). This means the focus is on comparing features and intended use, not on generating new performance data to meet specific, predefined acceptance criteria.
• Lack of Performance Data: The document does not report any specific performance metrics (e.g., accuracy, sensitivity, specificity, or objective measurements related to scaling effectiveness) for the SONICflex 2003 series. It describes the device and its intended use but does not present data from studies designed to quantify its performance.
• Absence of AI/ML Context: This device, an ultrasonic scaler, is a mechanical dental tool. The document does not indicate any AI or machine learning components. Therefore, questions related to AI/ML specific studies (MRMC, standalone algorithm performance, AI assistance effect size) are not applicable.

In summary, based on the provided text, I cannot complete the requested tables and information because the document focuses on demonstrating substantial equivalence of a physical dental tool, not on reporting performance data from studies against specific acceptance criteria.

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