FDA 510(k)

Neodent InLab 驗證流程

K 號：K252727 · 2026-01-07

申請人JJGC Indústria e Comércio de Materiais Dentários S.A.

決定日期2026-01-07

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Neodent InLab Validated Workflow is the device name listed in this FDA 510(k) record. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. It received FDA 510(k) clearance on 2026-01-07 under 510(k) number K252727. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Neodent InLab Validated Workflow?

Neodent InLab Validated Workflow is a medical device that received FDA 510(k) clearance on 2026-01-07. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K252727.

When did Neodent InLab Validated Workflow receive FDA 510(k) clearance?

Neodent InLab Validated Workflow received FDA 510(k) clearance on 2026-01-07, under 510(k) number K252727.

Who is the listed applicant for Neodent InLab Validated Workflow?

The FDA 510(k) record lists JJGC Indústria e Comércio de Materiais Dentários S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neodent InLab Validated Workflow?

The FDA product code for Neodent InLab Validated Workflow is NHA.