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K Number
K042972
Device Name
XP TECHNOLOGY ULTRASONIC SCALER
Manufacturer
AMERICAN EAGLE INSTRUMENTS, INC.
Date Cleared
2005-03-18

(141 days)

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

An ultrasonic scaling system is used by dental professionals as 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. This device is contraindicated for children and adults with synthetic teeth. This device should not be used on patients or by users who have a pacemaker.

Device Description

XP TECHNOLOGY Ultrasonic Scaler

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA for an ultrasonic scaler, not a study report. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the FDA found the device to be similar enough to existing, legally marketed devices to allow its sale, rather than requiring a new, independent study to prove specific performance criteria were met.

The document includes:

  • Trade/Device Name: XP TECHNOLOGY Ultrasonic Scaler
  • Indications For Use: "An ultrasonic scaling system is used by dental professionals as 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." It also lists contraindications for children and adults with synthetic teeth, and for patients/users with pacemakers.

However, it does not provide:

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

§ 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.