DeviceClearance

LingOral Dental Design System— 510(k) K260419

Substantially Equivalent

Hangzhou ChohoTech Co., Ltd.

FDA 510(k) clearance K260419 for LingOral Dental Design System, Substantially Equivalent on 2026-05-08. Applicant: Hangzhou ChohoTech Co., Ltd.. Device class: 2.

Summary

Hangzhou ChohoTech's LingOral Dental Design System is filed under PNN, orthodontic software.

Class II, 21 CFR 872.5470. Dental is both the classification panel and the review panel. It was a Traditional 510(k).

ChohoTech filed from Hangzhou, China. The decision came 88 calendar days after receipt (February 9 to May 8, 2026).

Clearance details

Applicant
Hangzhou ChohoTech Co., Ltd.
Product code
Product code PNN
Device class
Class 2
Regulation
21 CFR 872.5470
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hangzhou, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.