Ledex WL070+
FDA 510(k) K163605 · Dentmate Technology Co. , Ltd.
510(k) numberK163605
Submission
- Device name
- Ledex WL070+
- Applicant
- Dentmate Technology Co. , Ltd.
New Taipei, TW - Received
- December 21, 2016
- Decision date
- January 19, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Ledex WL070+ cleared by the FDA?
Ledex WL070+ (K163605) received a 510(k) decision of Substantially Equivalent on January 19, 2017, 29 days after the submission was received.
What is the product code of K163605?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.