Cleared Traditional

BOMEDENT Apex locator, WISMY Apex locator (K203836) - FDA 510(k) Clearance

K203836 · Changzhou Bomedent Medical Technology Co.,Ltd · Dental device
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Optimized for regulatory review, auditing and printing
Mar 2021
Decision
90d
Days
-
Risk

K203836 is an FDA 510(k) clearance for the BOMEDENT Apex locator, WISMY Apex locator. Classified as Locator, Root Apex (product code LQY).

Submitted by Changzhou Bomedent Medical Technology Co.,Ltd (Changzhou, CN). The FDA issued a Cleared decision on March 30, 2021 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 Changzhou Bomedent Medical Technology Co.,Ltd devices

Submission Details

510(k) Number K203836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2020
Decision Date March 30, 2021
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.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 10
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K203836.
Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
K232717 · Changzhou Haili Medical Co., Ltd. · Dec 2023
Root Apex Locator
K212178 · Foshan Coxo Medical Instrument Co., Ltd. · Jul 2022
EQ-PEX
K210789 · Meta Systems Co., Ltd. · Oct 2021
Propex IQ Apex Locator
K191806 · Dentsply Sirona · Oct 2019
Apex Locator, DPEX III
K181087 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dec 2018
Dr’s Finder NEO
K171867 · Good Doctors Co., Ltd. · Mar 2018