PiezoMed

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

510(k) Number

K133488 ↗

FDA product code

DZI

Device class

Class II

Regulation

21 CFR Part 872.4120

Advisory committee

Dental

FDA decision

SESE Substantially Equivalent

• Implantmed Plus II & Piezomed Plus II Module

  Class II

  FDA 510(k) K253776 Active Cleared 18 Jun 2026

• W&H Assistina Twin

  Class I

  FDA 510(k) K171553 Active Cleared 8 Dec 2017

• PROXEO Twist Cordless Polishing System PL-40 H

  Class I

  FDA 510(k) K201703 Active Cleared 24 Feb 2021

• Surgical Contra-Angel Handpieces Types Ws-56E, Ws-75E/Km, Ws-92 E/3, Surgical Straight Handpieces Types, S-9, S-10, S-11

  Class I

  CE/MDD CE/MDR +1authorizations

• Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)

  Class II

  FDA 510(k) K243280 Active Cleared 3 Jul 2025

• Surgical Handpieces, Mikro Saw Handpieces Open recall

  Class II

  FDA 510(k) K080939 Active Cleared 29 Jul 2008

See all devices from W&H Dentalwerk Buermoos GmbH →

• What makes the PiezoMed different from traditional bone drills in dental procedures?

  The PiezoMed uses high-frequency microvibrations and cavitation effects to create precise, minimally invasive bone surgery. Unlike traditional drills, this technology reduces tissue trauma and helps achieve blood-free surgical sites, making it ideal for delicate dental procedures where minimizing damage to surrounding tissues is critical.

• Is the PiezoMed a single-use device or reusable, and how should it be maintained?

  The PiezoMed is designed as a reusable dental instrument for clinical settings. Since it is reusable, proper cleaning, sterilization, and maintenance protocols must be followed as per manufacturer guidelines to ensure safety and functionality across multiple uses.

• What regulatory pathways has the PiezoMed followed, and which agencies have approved it?

  The PiezoMed has undergone FDA 510(k) clearance (K133488) under the Class II (Dental) regulatory classification, demonstrating substantial equivalence to a predicate device. It also complies with EU regulation 872.4120, ensuring alignment with European dental device standards.

• Are there multiple models of the PiezoMed, and how do I determine compatibility for my practice?

  Yes, the PiezoMed comes in multiple model variants, each identified by unique FEI numbers (e.g., 1000160293, 3004975279, etc.). These variants are designed for compatibility with different dental applications. To ensure the correct model for your practice, consult the manufacturer’s documentation or contact their support team with your specific use case.