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K Number
K053030
Device Name
J. MORITA AZ ULTRASONIC SYSTEM
Manufacturer
J. MORITA USA, INC.
Date Cleared
2005-11-07

(11 days)

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

The AZ Ultrasonic System is an Ultra Scaler intended for use with an appropriate tip for Periodontic, Endodontic, Scaling and Ultra (Prosthesis) use.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the AZ Ultrasonic System, which confirms that the device is substantially equivalent to a legally marketed predicate device.

It lists:

  • Trade/Device Name: AZ Ultrasonic System
  • Regulation Number: 21 CFR 872.4850
  • Regulation Name: Ultrasonic Scaler
  • Regulatory Class: II
  • Product Code: ELC
  • Indications For Use: The AZ Ultrasonic System is an Ultra Scaler intended for use with an appropriate tip for Periodontic, Endodontic, Scaling and Ultra (Prosthesis) use.

However, it does not include details on:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Standalone (algorithm only) performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

Therefore, I cannot fulfill your request with the information provided.

§ 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.