Cleared Traditional

K191806 - Propex IQ Apex Locator

K191806 · Dentsply Sirona · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
90d
Days
-
Risk

K191806 is an FDA 510(k) clearance for the Propex IQ Apex Locator. Classified as Locator, Root Apex (product code LQY).

Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on October 3, 2019 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentsply Sirona devices

FDA 510(k) Submission Details - K191806

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

LQY Device Classification - Class 0,

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 29
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K191806.
Root Apex Locator
K212178 · Foshan Coxo Medical Instrument Co., Ltd. · Jul 2022
EQ-PEX
K210789 · Meta Systems Co., Ltd. · Oct 2021
BOMEDENT Apex locator, WISMY Apex locator
K203836 · Changzhou Bomedent Medical Technology Co.,Ltd · Mar 2021
Apex Locator, DPEX III
K181087 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dec 2018
Dr’s Finder NEO
K171867 · Good Doctors Co., Ltd. · Mar 2018
Dr's Finder
K151274 · Good Doctors Co., Ltd. · Feb 2016