LEDEX
K-Number: K221194 · 2022-09-16
Device Summary
Frequently Asked Questions
What is the LEDEX?
LEDEX is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Dentmate Technology Co. , Ltd.. The 510(k) number is K221194.
When did LEDEX receive FDA 510(k) clearance?
LEDEX received FDA 510(k) clearance on 2022-09-16, under 510(k) number K221194.
Who is the listed applicant for LEDEX?
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?
The FDA product code for LEDEX 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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.