EzDent-i v2.2
EzDent-i v2.2 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Ewoosoft Co., Ltd., cleared under FDA 510(k) K163533 on 12 Jan 2017 and listed in FDA GUDID since 13 Feb 2017 (UDI-DI 08800019700050), 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 | Number08800019700050 | Date13 Feb 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163533 | Date12 Jan 2017 | StatusActive |
Official records
- AccessGUDID record 08800019700050
- FDA 510(k) database K163533
Across registries
- FDA 510(k) K163533 decided 12 Jan 2017 Active
- FDA GUDID UDI-DI 08800019700050 listed 13 Feb 2017 Listed
Timeline
- Cleared FDA 510(k) K163533
- Listed FDA GUDID 08800019700050
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EzDent-i
- Generic name
- General-purpose dental x-ray system application software
- Model / reference
- v2.2
- Primary DI / UDI-DI
- 08800019700050
- 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