Surgical devices · 21 CFR 872 Subpart E
Water-Powered Handpiece
FDA device type “Handpiece, Water-Powered”.
- Companies listing it
- 21 makers
- Brands and models
- 5
- 510(k) clearances
- 20 in five years
- FDA name
- Handpiece, Water-Powered
510(k) clearances per year, 1976–2026
Companies that list EKY
2 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Saeshin Precision Co., Ltd. | South Korea | Maker | BIODENT SIP10 · Maxima Elite i · Maxima Elite iL · TRAUS SIP 10 | 16 | 2026 |
| DIO Corporation | South Korea | Foreign exporter | TRAUS | 14 | 2023 |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 18 Dec 2012 | K123695 | TRAUS SIP10 | Saeshin Precision Co., Ltd. |
| 19 Jul 1990 | K896364 | DECIDENT | Nevin Laboratories, Inc. |
Official records: FDA product classification for EKY · 21 CFR 872.4200.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026