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K Number
K053555
Device Name
ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L
Manufacturer
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD
Date Cleared
2006-08-21

(244 days)

Product Code
ELC
Regulation Number
872.4850
Type
Traditional
Panel
DE
Reference & Predicate Devices
K053555
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Model :UDS-J/K/N1/N2 :

  1. Removing supra and sub gingival calculus deposits and stains from the teeth

  2. Periodontal pocket lavage with simultaneous ultrasonic tip movement

Model: UDS-L :

    1. Removing supra and sub gingival calculus deposits and stains from the teeth
      AND/OR

  1. Periodontal pocket lavage with simultaneous ultrasonic tip movement

  2. Preparing, cleaning, and irrigating root canals

  3. Retrograde preparation of root canals

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text only contains a letter from the FDA regarding a 510(k) premarket notification for an ultrasonic scaler. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

The document does not contain any information regarding:

  • Acceptance criteria for device performance.
  • A study that demonstrates the device meets acceptance criteria.
  • Performance metrics of the device.
  • Sample sizes for test or training sets.
  • Data provenance.
  • Number or qualifications of experts for ground truth.
  • Adjudication methods.
  • MRMC comparativeeffectiveness studies.
  • Standalone performance.
  • Type of ground truth used.
  • How ground truth for training was established.

Therefore, I cannot fulfill your request for this specific information based on the provided text.

§ 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.