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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 510K
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.
Clinical Applications
Commonly used in oral and maxillofacial surgery, the Piezomed Pro is ideal for procedures like sinus lifts, ridge splitting, and osteotomies. It is also used in periodontal surgery and endodontics. The device is suitable for outpatient surgical settings and is used by oral surgeons, periodontists, and implantologists treating adult patients requiring bone modification.
Indications for Use
The FDA-cleared indications for the Piezomed Pro involve its use in surgeries that require precise bone cutting without damaging adjacent soft tissues. It is particularly indicated for patients undergoing dental surgeries where bone manipulation is necessary.
Practical Considerations
The Piezomed Pro comes with various tips and accessories to accommodate different surgical needs. It is compatible with standard surgical handpieces and requires specific training for optimal use. Clinicians should ensure proper device calibration and maintenance for consistent performance.
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.