FDA 510(k)

RAYDENT SW

K-Number: K233625 · 2024-05-16

Decision Date2024-05-16

Product CodePNN

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

RAYDENT SW 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 2024-05-16 under 510(k) number K233625. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAYDENT SW?

RAYDENT SW is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is Ray Co., Ltd.. The 510(k) number is K233625.

When did RAYDENT SW receive FDA 510(k) clearance?

RAYDENT SW received FDA 510(k) clearance on 2024-05-16, under 510(k) number K233625.

Who is the listed applicant for RAYDENT SW?

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 RAYDENT SW?

The FDA product code for RAYDENT SW is PNN.

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 K251109SMARTDent K243903RCT600 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.