SMARTDent
K-Number: K251109 · 2025-05-21
ApplicantRay Co., Ltd.
Decision Date2025-05-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SMARTDent is a medical device manufactured by Ray Co., Ltd.. It received FDA 510(k) clearance on 2025-05-21 under approval number K251109. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SMARTDent?
SMARTDent is a medical device that received FDA 510(k) clearance on 2025-05-21. It is manufactured by Ray Co., Ltd.. The 510(k) number is K251109.
When was SMARTDent approved by the FDA?
SMARTDent received FDA 510(k) clearance on 2025-05-21, under approval number K251109.
What company makes SMARTDent?
SMARTDent is manufactured by Ray Co., Ltd..
What is the FDA product code for SMARTDent?
The FDA product code for SMARTDent is LLZ.
Other Devices by Ray Co., Ltd.
Related Devices (Code: LLZ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.