Cleared Traditional

K212178 - Root Apex Locator (FDA 510(k) Clearance)

K212178 · Foshan Coxo Medical Instrument Co., Ltd. · Dental device
Jul 2022
Decision
373d
Days
-
Risk

K212178 is an FDA 510(k) clearance for the Root Apex Locator. This device is classified as a Locator, Root Apex.

Submitted by Foshan Coxo Medical Instrument Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on July 20, 2022, 373 days after receiving the submission on July 12, 2021.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K212178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2021
Decision Date July 20, 2022
Days to Decision 373 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LQY - Locator, Root Apex
Device Class -