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Piezomed Pro Piezomed Pro Module M-Pm100 Incl Handpiece M-Ph350 Piezomed Pro Instruments Various TIPS and Accessories
W&H Dentalwerk Buermoos
Summary: The Piezomed Pro Module M-PM100 is a surgical device used for precise bone cutting, typically in dental and maxillofacial surgeries. It is utilized by oral surgeons and dental professionals.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K243280 ↗
Decision Date ?
July 3, 2025
Product Code ?
ERL
Device Class ?
Class 2
Evidence ?
0 studies
The Piezomed Pro Module M-PM100 by W&H Dentalwerk was cleared via the FDA 510k pathway on July 3, 2025. It is classified as a Class 2 device under product code ERL.
What It Is
The Piezomed Pro is a piezoelectric surgical device designed for cutting bone with precision and minimal trauma to surrounding tissues. It operates using ultrasonic vibrations, allowing for selective cutting of mineralized structures while preserving soft tissue. This technology is particularly beneficial in procedures requiring high precision and control, such as dental implantology and bone grafting.
FDA-Cleared Indications
- Use for cutting and preparing mineralized tissue during oral and maxillofacial surgical procedures.
- The system is intended for use with compatible Piezomed Pro handpieces, instruments, tips, and accessories.
- Use is limited to the procedures, tissues, instruments, and operating conditions described in the FDA-cleared labeling.
Clinical Applications
- Controlled bone cutting during oral and maxillofacial surgery.
- Bone preparation associated with dental implant procedures.
- Bone grafting procedures requiring osteotomy or other bone modification.
- Sinus-lift and ridge-modification procedures when performed with labeled instruments and technique.
- Periodontal or endodontic procedures involving indicated mineralized-tissue preparation.
Practical Considerations
- The system is supplied as a module with a compatible handpiece, such as the M-PH350, and multiple procedure-specific tips and accessories.
- Only compatible, approved instruments and accessories should be used; tip selection affects the intended cutting action and surgical approach.
- The operator should follow the manufacturer's instructions for irrigation, power settings, calibration, cleaning, sterilization, and maintenance.
- This is an ultrasonic bone-cutting system, not an MRI device; the module, handpiece, and accessories should not be taken into the MRI environment unless the manufacturer provides specific MRI-conditional labeling.
- Use requires training in ultrasonic surgical instrumentation and attention to nearby soft tissue, nerves, teeth, implants, and other anatomic structures.
Frequently Asked Questions
What is Piezomed Pro used for?
The Piezomed Pro is used for precise bone cutting in dental and maxillofacial surgeries, minimizing trauma to soft tissues.
What specialties typically use this device?
This device is typically used by oral surgeons, periodontists, and dental implantologists.
What are the FDA-cleared indications?
The device is indicated for surgeries requiring precise bone cutting, particularly in dental and maxillofacial procedures.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.