# K253776: Implantmed Plus II & Piezomed Plus II Module

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Buermoos GmbH
- Decided: Jun 18, 2026 after 204 days
- Product code: DZI (Drill, Bone, Powered)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002469 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161957: W&H Implantmed SI-1015 incl. Accessories, W&H Dentalwerk Burmoos GmbH (2016) Summary page 5.
- K133488: Piezomed, W&H Dentalwerk Buermoos GmbH (2014) Summary page 5.

## Indications for use
Implantmed Plus II: Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (MF) for treatment of dental hard tissue. Piezomed Plus Module II: Piezoelectric ultrasonic device, consisting of handpieces and associated instruments, intended for: bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures. Scaling applications are including: - Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits, - Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning, - Endodontic: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha-condensation and retrograde preparation, - Restorative and prosthetics: Cavity preparation, removal of prostheses, finishing of crown preparations.

Source page: https://510kreport.com/device/K253776
Methodology: https://510kreport.com/methodology