FDA 510(k)

SMARTDent

K-Number: K251109 · 2025-05-21

Decision Date2025-05-21

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SMARTDent is the device name listed in this FDA 510(k) record. The listed applicant is Ray Co., Ltd.. It received FDA 510(k) clearance on 2025-05-21 under 510(k) 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. The listed applicant is Ray Co., Ltd.. The 510(k) number is K251109.

When did SMARTDent receive FDA 510(k) clearance?

SMARTDent received FDA 510(k) clearance on 2025-05-21, under 510(k) number K251109.

Who is the listed applicant for SMARTDent?

The FDA 510(k) record lists Ray Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTDent?

The FDA product code for SMARTDent is LLZ.

Other records listing Ray Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260462RCT800 K251798RCT700 K243903RCT600 K233625RAYDENT SW K232325RAYSCAN a-Expert K232287RAYSCAN a-Expert3D

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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.