SMARTDent
by Ray Co., Ltd
510(k) K251109
SMARTDent is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Ray Co., Ltd, cleared under FDA 510(k) K251109 on 21 May 2025, 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 | NumberK251109 | Date21 May 2025 | StatusActive |
Official records
- FDA 510(k) database K251109
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- FDA applicant
- Ray Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K251109
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 | |||
|---|---|---|---|---|
| SMARTDent 3.1.0.0 | 3.1.0.0 | 08800003005017 | — | On the market |
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