FDA 510(k)

LingOral Dental Design System

Número K: K260419 · 2026-05-08

Data da decisão2026-05-08

Código do produtoPNN

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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