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Compact Piezo P2K

by Mectron S.p.A.

510(k) K102218

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 NumberK102218 Date24 Jan 2011ClearedStatusActive

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  • Withdrawn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)

Full name
Compact Piezo P2K, Powercare
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, 1 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 Compact Piezo P2K is an ultrasonic dental scaler designed for precision periodontal and subgingival cleaning. It employs piezoelectric technology to generate high-frequency vibrations that efficiently remove plaque, calculus, and biofilm from tooth surfaces and root areas, aiding in periodontal therapy and maintenance.

This device integrates with dental units, featuring built-in controls and a handpiece housed within the unit’s holder to optimize space efficiency. Supplied as a reusable instrument, it requires proper sterilization between uses and is classified as Class II under FDA regulations (510(k) clearance K102218). Compliance with dental specialty standards ensures its use in clinical settings for scaling procedures, with no MRI safety restrictions specified.

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Questions

AI-generated answers, 1 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 Compact Piezo P2K ultrasonic scaler used for?

    The Compact Piezo P2K is designed for precision periodontal and subgingival cleaning. It uses piezoelectric technology to generate high-frequency vibrations that effectively remove plaque, calculus, and biofilm from tooth surfaces and root areas, supporting periodontal therapy and maintenance procedures.

  • How is the Compact Piezo P2K supplied and what are its sterilization requirements?

    The Compact Piezo P2K is supplied as a reusable instrument. Due to its reusable nature, it must undergo proper sterilization between uses to ensure patient safety and device efficacy. Sterilization protocols should align with clinical best practices for dental instruments.

  • Is the Compact Piezo P2K single-use or reusable?

    The Compact Piezo P2K is a reusable ultrasonic scaler. Its design allows for integration into dental units, and it is intended to be used repeatedly with appropriate sterilization between patients to maintain hygiene and functionality.

  • Does the Compact Piezo P2K have any size or model variations?

    The device data provided does not specify multiple size or model variations for the Compact Piezo P2K. It is marketed as a single model designed for space-efficient integration into dental units, focusing on precision cleaning for periodontal and subgingival areas.

  • What storage requirements does the Compact Piezo P2K have?

    While specific storage instructions are not detailed in the provided data, reusable ultrasonic scalers like the Compact Piezo P2K generally require clean, dry storage in a protected environment to prevent contamination or damage. Ensure the device is fully sterilized and stored according to manufacturer guidelines to maintain its performance and longevity.