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FDA 510(k)

LEDEX WL070+

K-Number: K163605 · 2017-01-19

Decision Date2017-01-19
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LEDEX WL070+ is the device name listed in this FDA 510(k) record. The listed applicant is Dentmate Technology Co. , Ltd.. It received FDA 510(k) clearance on 2017-01-19 under 510(k) 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. The listed applicant is Dentmate Technology Co. , Ltd.. The 510(k) number is K163605.

When did LEDEX WL070+ receive FDA 510(k) clearance?

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

Who is the listed applicant for LEDEX WL070+?

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

What is the FDA product code for LEDEX WL070+?

The FDA product code for LEDEX WL070+ is EBZ.

Other records listing Dentmate Technology 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.

Related Devices (Code: EBZ)

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.

Official Source

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