EzOrtho 1.0
EzOrtho 1.0 is a Class II device made by Ewoosoft Co., Ltd., cleared under FDA 510(k) K192888 on 13 Mar 2020 and listed in FDA GUDID since 25 Nov 2020 (UDI-DI 08800019700159), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08800019700159 | Date25 Nov 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192888 | Date13 Mar 2020 | StatusActive |
Official records
- AccessGUDID record 08800019700159
- FDA 510(k) database K192888
Across registries
- FDA 510(k) K192888 decided 13 Mar 2020 Active
- FDA GUDID UDI-DI 08800019700159 listed 25 Nov 2020 Listed
Timeline
- Cleared FDA 510(k) K192888
- Listed FDA GUDID 08800019700159
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EzOrtho
- Generic name
- General-purpose dental x-ray system application software
- Model / reference
- 1.0
- Primary DI / UDI-DI
- 08800019700159
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- General-purpose dental x-ray system application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under General-purpose dental x-ray system application software.