# K243280: Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Buermoos GmbH
- Decided: Jul 3, 2025 after 259 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K862807 (1986). 31 ancestors in all.
No later device cites it as a predicate yet.
1 of 32 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153743: Piezosurgery Plus, Mectron S.P.A. (2016) Summary page 6.

## Indications for use
The piezoelectric surgical system is indicated for: osteotomies, osteoplasties, drilling and shaping of hard tissue. Including: - Otolaryngology, - Maxillofacial surgery, - hand- & foot-surgery and - plastic & reconstructive surgery.

Source page: https://510kreport.com/device/K243280
Methodology: https://510kreport.com/methodology