EzDent-i / E2 / Prora View
by Ewoosoft Co., Ltd. 3 variants
510(k) K190087
EzDent-i / E2 / Prora View is a Class II device made by Ewoosoft Co., Ltd., cleared under FDA 510(k) K190087 on 27 Feb 2019, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK190087 | Date27 Feb 2019 | StatusActive |
Official records
- FDA 510(k) database K190087
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K190087
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| EzDent-i v3.0 | v3.0 | 08800019700111 | On the market | |
| Smart M Viewer v3.0 | v3.0 | 08800019700180 | On the market |
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