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Proxeo ULTRA (PB-510, PB-520 and PB-530)

by W&H Dentalwerk Buermoss GmbH

510(k) K223173

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK223173 Date14 Jul 2023ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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, 6 Oct 2026

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

The Proxeo ULTRA is an ultrasonic scaler device used in dental prophylaxis procedures. It is available in three models: PB-510, PB-520, and PB-530. This device is designed for efficient dental scaling and polishing applications.

The Proxeo ULTRA is supplied as a reusable device and requires a wireless foot control for operation. It is not MRI compatible and may affect implantable systems such as cardiac pacemakers. The device has received FDA 510(k) clearance with product code ELC.

Other devices from W&H Dentalwerk Buermoss GmbH

Questions

AI-generated answers, 6 Oct 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 Proxeo ULTRA used for in dental practice?

    The Proxeo ULTRA is an ultrasonic scaler device designed for efficient dental scaling and polishing applications during dental prophylaxis procedures. It helps dental professionals remove plaque, calculus, and stains from teeth surfaces.

  • How is the Proxeo ULTRA supplied and operated?

    The Proxeo ULTRA is supplied as a reusable device that requires a wireless foot control for operation. This allows clinicians to easily control the device during dental procedures while maintaining a sterile environment.

  • Are there different models available for the Proxeo ULTRA?

    Yes, the Proxeo ULTRA is available in three models: PB-510, PB-520, and PB-530. These models may offer different features or specifications to meet various clinical needs in dental practice.

  • What precautions should be taken when using the Proxeo ULTRA?

    The Proxeo ULTRA is not MRI compatible and may affect implantable systems such as cardiac pacemakers. Dental professionals should take appropriate precautions when using this device with patients who have such medical implants.