# K213221: AMADEO, M-UK1015 (incl. attachments and accessories)

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Buermoss GmbH
- Decided: May 26, 2022 after 239 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: 8 generations back to K931783 (1993). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132264: PRIMADO2 Total Surgical System, Nakanishi, Inc. (2013) Summary page 5.

## Most influential descendants
- K240340: Surgical Drive System (Model: ES70, ES90, E8) (2024), 0 descendants of its own

## Indications for use
The drive unit for surgical transmission instruments is indicated for: drilling, milling, cutting, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery and Maxillofacial surgery

Source page: https://510kreport.com/device/K213221
Methodology: https://510kreport.com/methodology