Cleared Traditional

K252224 - Apex Locator (FindPex) (FDA 510(k) Clearance)

K252224 · Changzhou Sifary Medical Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
266d
Days
-
Risk

K252224 is an FDA 510(k) clearance for the Apex Locator (FindPex). Classified as Locator, Root Apex (product code LQY).

Submitted by Changzhou Sifary Medical Technology Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on April 8, 2026 after a review of 266 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 Changzhou Sifary Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K252224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2025
Decision Date April 08, 2026
Days to Decision 266 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
139d slower than avg
Panel avg: 127d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -