Data / Medical devices / Scaler, Ultrasonic / Taiwan
FDA-registered makers of Scaler, Ultrasonic in Taiwan: 5 establishments
5 establishments in Taiwan are registered with the FDA to make Scaler, Ultrasonic (product code ELC). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Scaler, Ultrasonic
- Product code
- ELC
- Country
- Taiwan
Makers of Scaler, Ultrasonic in Taiwan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bonart Co. Ltd. | Keelung, Taiwan | Contract manufacturer, Manufacturer | 6 | August 28, 2008 | 0 | 0 | 0 | api.fda.gov |
| Ttbio Corporation | Taichung, Taiwan | Manufacturer | 2 | February 2, 2022 | 0 | 0 | 0 | api.fda.gov |
| Apoza Enterprise Co., Ltd. | Hsin-Chuang District New Taipei, Taiwan | Manufacturer | 1 | April 30, 2004 | 0 | 0 | 0 | api.fda.gov |
| Dhef Inc. | New Taipei City, Taiwan | Manufacturer | 1 | January 18, 1996 | 0 | 0 | 0 | api.fda.gov |
| Rolence Ent. Inc. | CHUNGLI Taoyuan, Taiwan | Exporter to the US, Manufacturer | 1 | April 22, 2004 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.