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FDA 510(k)

LEDEX

K-Number: K221194 · 2022-09-16

ApplicantDentmate Technology Co. , Ltd.
Decision Date2022-09-16
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LEDEX is a medical device manufactured by Dentmate Technology Co. , Ltd.. It received FDA 510(k) clearance on 2022-09-16 under approval number K221194. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEDEX?

LEDEX is a medical device that received FDA 510(k) clearance on 2022-09-16. It is manufactured by Dentmate Technology Co. , Ltd.. The 510(k) number is K221194.

When was LEDEX approved by the FDA?

LEDEX received FDA 510(k) clearance on 2022-09-16, under approval number K221194.

What company makes LEDEX?

LEDEX is manufactured by Dentmate Technology Co. , Ltd..

What is the FDA product code for LEDEX?

The FDA product code for LEDEX is EBZ.

Other Devices by Dentmate Technology Co. , Ltd.

K163605LEDEX WL070+

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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.

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