Data / Medical devices / Taiwan / Inteware Co., Ltd
Inteware Co., Ltd: FDA-registered device maker in Chiayi County Chiayi(County), Taiwan, 2 510(k) clearances
Inteware Co., Ltd is registered with the FDA (registration 3013912897) in Chiayi County Chiayi(County), Taiwan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 12, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013912897
- Address
- 4F.,No.93,Xinzheng 5th St., MingXiong Township, Chiayi County Chiayi(County), Taiwan, 62145
- Owner or operator
- Inteware Co., Ltd (10056771)
- Roles
- Manufacturer
- First device listed
- January 14, 2018
- Registered through
- 2026
- Brand names listed
- AirDesign, EZCAD, Implant Planning Software, OrthoAnalysis Software
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthodontic Software | PNN | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 12, 2019 | K183695 | OrthoAnalysis Software | PNN | Substantially Equivalent | Inteware Co., Ltd. | accessdata.fda.gov |
| October 26, 2018 | K173965 | Implant Planning Software | LLZ | Substantially Equivalent | Inteware Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- All makers of System, Image Processing, Radiological
- All makers of Orthodontic Software
Updated September 12, 2019. 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.