FDA 510(k)

LingOral Dental Design System

K-Number: K260419 · 2026-05-08

Decision Date2026-05-08

Product CodePNN

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

LingOral Dental Design System is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou ChohoTech Co., Ltd.. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K260419. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LingOral Dental Design System?

LingOral Dental Design System is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is Hangzhou ChohoTech Co., Ltd.. The 510(k) number is K260419.

When did LingOral Dental Design System receive FDA 510(k) clearance?

LingOral Dental Design System received FDA 510(k) clearance on 2026-05-08, under 510(k) number K260419.

Who is the listed applicant for LingOral Dental Design System?

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

What is the FDA product code for LingOral Dental Design System?

The FDA product code for LingOral Dental Design System is PNN.

Related Devices (Code: PNN)

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.

K253565SureSmile SoftwareDentsply Sirona, Inc.K252507SmileInspectorAmv Consulting, LLC K253343Celebrace SoftwareCelebrace K250198Laon OrthoLaon Medi, Inc.K241153Progressive Orthodontics AppProgressive Aligners, Inc.K233625RAYDENT SWRay Co., Ltd.

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.