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 an endodontic device that finds the end of the root canal during treatment by measuring electrical impedance as the file advances. Product code LQY covers root apex locators.
The record lists the device class as U, for unclassified, with no regulation number, and the advisory panel as Unknown, even though LQY is a dental code. It was 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
- 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 →
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