EzDent-i 3.3
EzDent-i 3.3 is a Class II device made by Ewoosoft Co., Ltd., cleared under FDA 510(k) K222145 on 12 Aug 2022 and listed in FDA GUDID since 13 Oct 2022 (UDI-DI 08800019700357), 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 | Number08800019700357 | Date13 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222145 | Date12 Aug 2022 | StatusActive |
Official records
- AccessGUDID record 08800019700357
- FDA 510(k) database K222145
Across registries
- FDA 510(k) K222145 decided 12 Aug 2022 Active
- FDA GUDID UDI-DI 08800019700357 listed 13 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K222145
- Listed FDA GUDID 08800019700357
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- Withdrawn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
- 3.3
- Primary DI / UDI-DI
- 08800019700357
- 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.