K252224
Substantially EquivalentApex Locator (FindPex)
The Apex Locator (FindPex) is an endodontic instrument — product code LQY covers apex locators used in root canal treatment to determine the working length of the root canal by measuring electrical impedance changes. It's a mature dental-endodontic category with a well-established predicate set.
Panel assignment shows "Unknown" in our data but LQY sits in the Dental panel. Traditional 510(k). Apex locators are mechanically and electrically simple devices; clearances turn on specification comparisons and safety testing.
Changzhou Sifary Medical Technology files from Changzhou, China. Nine-month review clock. Chinese dental-instrument manufacturers have become routine filers on LQY.
- Applicant
- Changzhou Sifary Medical Technology Co., Ltd.
- Product code
- LQY
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changzhou, CN
Adverse 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.