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FDA 510(k)

LEDEX WL070+

K-Number: K163605 · 2017-01-19

ApplicantDentmate Technology Co. , Ltd.
Decision Date2017-01-19
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LEDEX WL070+ is a medical device manufactured by Dentmate Technology Co. , Ltd.. It received FDA 510(k) clearance on 2017-01-19 under approval number K163605. 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 WL070+?

LEDEX WL070+ is a medical device that received FDA 510(k) clearance on 2017-01-19. It is manufactured by Dentmate Technology Co. , Ltd.. The 510(k) number is K163605.

When was LEDEX WL070+ approved by the FDA?

LEDEX WL070+ received FDA 510(k) clearance on 2017-01-19, under approval number K163605.

What company makes LEDEX WL070+?

LEDEX WL070+ is manufactured by Dentmate Technology Co. , Ltd..

What is the FDA product code for LEDEX WL070+?

The FDA product code for LEDEX WL070+ is EBZ.

Other Devices by Dentmate Technology Co. , Ltd.

K221194LEDEX

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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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