Cleared Traditional

K181087 - Apex Locator, DPEX III (FDA 510(k) Clearance)

K181087 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dental device
Dec 2018
Decision
237d
Days
-
Risk

K181087 is an FDA 510(k) clearance for the Apex Locator, DPEX III. This device is classified as a Locator, Root Apex.

Submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Guilin City, CN). The FDA issued a Cleared decision on December 18, 2018, 237 days after receiving the submission on April 25, 2018.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K181087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2018
Decision Date December 18, 2018
Days to Decision 237 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LQY - Locator, Root Apex
Device Class -