SMARTDent
FDA 510(k) K251109 · Ray Co., Ltd.
510(k) numberK251109
Submission
- Device name
- SMARTDent
- Applicant
- Ray Co., Ltd.
Yongin-Si, KR - Received
- April 11, 2025
- Decision date
- May 21, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was SMARTDent cleared by the FDA?
SMARTDent (K251109) received a 510(k) decision of Substantially Equivalent on May 21, 2025, 40 days after the submission was received.
What is the product code of K251109?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.