ZSmile System
K-Number: K253282 · 2026-02-03
ApplicantDror Orthodesign , Ltd.
Decision Date2026-02-03
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ZSmile System is a medical device manufactured by Dror Orthodesign , Ltd.. It received FDA 510(k) clearance on 2026-02-03 under approval number K253282. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ZSmile System?
ZSmile System is a medical device that received FDA 510(k) clearance on 2026-02-03. It is manufactured by Dror Orthodesign , Ltd.. The 510(k) number is K253282.
When was ZSmile System approved by the FDA?
ZSmile System received FDA 510(k) clearance on 2026-02-03, under approval number K253282.
What company makes ZSmile System?
ZSmile System is manufactured by Dror Orthodesign , Ltd..
What is the FDA product code for ZSmile System?
The FDA product code for ZSmile System is NXC.
Related Devices (Code: NXC)
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.