FDA 510(k)

ZSmile System

K-Number: K253282 · 2026-02-03

Decision Date2026-02-03

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ZSmile System is the device name listed in this FDA 510(k) record. The listed applicant is Dror Orthodesign , Ltd.. It received FDA 510(k) clearance on 2026-02-03 under 510(k) 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. The listed applicant is Dror Orthodesign , Ltd.. The 510(k) number is K253282.

When did ZSmile System receive FDA 510(k) clearance?

ZSmile System received FDA 510(k) clearance on 2026-02-03, under 510(k) number K253282.

Who is the listed applicant for ZSmile System?

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

What is the FDA product code for ZSmile System?

The FDA product code for ZSmile System is NXC.

Other records listing Dror Orthodesign , 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.