Apex Locator (FindPex)— 510(k) K252224
Substantially EquivalentChangzhou Sifary Medical Technology Co., Ltd.
FDA 510(k) clearance K252224 for Apex Locator (FindPex), Substantially Equivalent on 2026-04-08. Applicant: Changzhou Sifary Medical Technology Co., Ltd.. Device class: Unclassified.
Summary
The Apex Locator (FindPex) is filed under LQY, root apex locators. The record doesn't describe how it works.
The record lists the device class as U, for unclassified, with no regulation number, and the advisory panel as Unknown. The Dental panel reviewed it as a Traditional 510(k).
Changzhou Sifary Medical Technology filed from Changzhou, China. Review took 266 days (July 16, 2025 to April 8, 2026).
Clearance details
- Applicant
- Changzhou Sifary Medical Technology Co., Ltd.
- Product code
- Product code LQY
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changzhou, CN
Recent devices under product code LQY
view allMore clearances from Changzhou Sifary Medical Technology Co., Ltd.
view allAdverse events under product code LQY
product code LQY- Malfunction
- 504
- Total
- 504
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.