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

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

510(k) Number

K243280 ↗

FDA Product Code

ERL

Device Class

Class II

Regulation

21 CFR Part 874.4250

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Implantmed Plus II & Piezomed Plus II Module

  Class II

  FDA 510(k) K253776 Active Cleared 18 Jun 2026

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  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

• Surgical Handpieces, Mikro Saw Handpieces Open recall

  Class II

  FDA 510(k) K080939 Active Cleared 29 Jul 2008

• Prosthodontic Screwdriver, Model Ia-400

  Class I

  FDA 510(k) K100600 Active Cleared 9 Jul 2010

See all devices from W&H Dentalwerk Buermoos GmbH →

• What types of surgical procedures is the Piezomed Pro designed for, and why is piezoelectric technology preferred in these cases?

  The Piezomed Pro is specifically designed for precise osteotomies, osteoplasties, and hard tissue drilling/shaping, commonly used in otolaryngology and maxillofacial surgery. Piezoelectric technology is preferred because it enables controlled cutting of bone and hard tissue with minimal trauma to surrounding soft tissues, reducing the risk of thermal damage or unintended injury.

• Is the Piezomed Pro system reusable, and if so, how should it be maintained to ensure sterility?

  Yes, the Piezomed Pro is supplied as a reusable system, including the module (M-PM100), handpiece (M-PH350), and interchangeable tips. To maintain sterility, the system must be cleaned and sterilized according to manufacturer guidelines in clinical settings where sterile conditions are strictly maintained, as it is intended for surgical use.

• What regulatory pathway was followed for the FDA clearance of the Piezomed Pro, and what does this mean for clinicians?

  The Piezomed Pro received FDA clearance under the 510(k) pathway (K243280), determined to be *substantially equivalent* to predicate devices. This means the device meets FDA standards for safety and effectiveness as a *Drill, Surgical, Ent (Electric or Pneumatic)*, and clinicians can rely on its regulatory review by the Ear, Nose, and Throat (ENT) advisory committee for use in otolaryngology and related procedures.

• Does the Piezomed Pro come with multiple tip options, and how do I determine which tip is best for my procedure?

  Yes, the Piezomed Pro includes a variety of interchangeable tips designed for different surgical applications. While the exact specifications for each tip aren’t detailed here, the system’s piezoelectric technology allows for controlled precision, so the choice of tip depends on the specific bone or hard tissue shaping required—consult the manufacturer’s documentation or surgical guidelines for compatibility with your procedure.

• What storage conditions should be followed for the Piezomed Pro system to ensure optimal performance and longevity?

  The Piezomed Pro system, being reusable, should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. After use, it must undergo proper cleaning and sterilization before storage to prevent contamination. Always follow the manufacturer’s instructions for maintenance to ensure the module, handpiece, and accessories remain functional and safe for repeated use.