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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

2. Periodontal pocket lavage with simultaneous ultrasonic tip movement

3. Preparing, cleaning, and irrigating root canals

4. Retrograde preparation of root canals

Not Found

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.

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