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Ultrasonic Scaler Elegance MS-10 (25K)

by Rolence Enteprise, Inc.

510(k) K040396

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K040396↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK040396 Date22 Apr 2004ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
ELC
Device Class
Class II
Regulation
21 CFR Part 872.4850
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ultrasonic Scaler Elegance MS-10 (25K) is a dental ultrasonic scaler designed for periodontal and subgingival cleaning. It uses high-frequency ultrasonic vibrations to remove plaque, calculus, and biofilm from teeth and surrounding structures, aiding in periodontal therapy and maintenance of oral health.

This device is intended for use in dental offices and clinics, supplied as a reusable instrument. It operates at a frequency of 25 kHz and is classified as a Class II medical device under FDA regulations. The scaler requires proper maintenance, including cleaning and sterilization between uses, and must comply with MRI safety standards for dental settings. Authorizations include FDA 510K clearance and MDD compliance.

Other devices from Rolence Enteprise, Inc.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary use of the Ultrasonic Scaler Elegance MS-10 (25K) in dental procedures?

    The Ultrasonic Scaler Elegance MS-10 (25K) is specifically designed for periodontal and subgingival cleaning. It uses high-frequency ultrasonic vibrations (25 kHz) to efficiently remove plaque, calculus, and biofilm from teeth and surrounding gum structures, supporting periodontal therapy and oral health maintenance in dental offices and clinics.

  • Is the Ultrasonic Scaler Elegance MS-10 (25K) intended for single-use or reusable applications?

    The device is supplied as a reusable instrument, meaning it must be properly cleaned, maintained, and sterilized between uses to ensure safety and effectiveness. Routine maintenance is required to comply with dental practice standards.

  • What regulatory pathways has the Ultrasonic Scaler Elegance MS-10 (25K) followed for market authorization?

    The device holds FDA 510K clearance and complies with the Medical Device Directive (MDD). It was determined *substantially equivalent* to a predicate device under the FDA’s traditional clearance process, with a decision date of April 22, 2004, and is classified as a Class II medical device.

  • Does the Ultrasonic Scaler Elegance MS-10 (25K) need to meet any specific safety standards for use in dental settings?

    Yes, the device must comply with MRI safety standards for dental environments, as noted in its specifications. This ensures it can be safely used in facilities where MRI equipment is present.

  • What should clinicians consider regarding storage and maintenance of the Ultrasonic Scaler Elegance MS-10 (25K)?

    While the device’s storage conditions aren’t explicitly detailed, its reusable nature requires adherence to standard dental instrument protocols—including cleaning, sterilization, and regular maintenance—to prevent contamination and ensure longevity. Follow manufacturer guidelines for optimal performance and compliance with infection control standards.