Cleared Traditional

K242383 - Apex Locator (FDA 510(k) Clearance)

K242383 · Shenzhen Rogin Medical Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
207d
Days
-
Risk

K242383 is an FDA 510(k) clearance for the Apex Locator. Classified as Locator, Root Apex (product code LQY).

Submitted by Shenzhen Rogin Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 7, 2025 after a review of 207 days - an extended review cycle.

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 Shenzhen Rogin Medical Co., Ltd. devices

Submission Details

510(k) Number K242383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2024
Decision Date March 07, 2025
Days to Decision 207 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
80d slower than avg
Panel avg: 127d · This submission: 207d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Consultant

Imd Medical & Drug Technology Service Institutions
Salon Chen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LQY Locator, Root Apex

All 45
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K242383.
Apex Locator (FindPex)
K252224 · Changzhou Sifary Medical Technology Co., Ltd. · Apr 2026
Electronic Apex Locator (Alpha Apex I)
K242765 · SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. · Jan 2025
Apex Locator
K231990 · Cefla S.C. · Feb 2024
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