Cleared Traditional

K191806 - Propex IQ Apex Locator (FDA 510(k) Clearance)

K191806 · Dentsply Sirona · Dental device
Oct 2019
Decision
90d
Days
—
Risk

K191806 is an FDA 510(k) clearance for the Propex IQ Apex Locator. This device is classified as a Locator, Root Apex.

Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on October 3, 2019, 90 days after receiving the submission on July 5, 2019.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K191806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2019
Decision Date October 03, 2019
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LQY — Locator, Root Apex
Device Class —