Propex IQ Apex Locator
FDA 510(k) K191806 · Dentsply Sirona
510(k) numberK191806
Submission
- Device name
- Propex IQ Apex Locator
- Applicant
- Dentsply Sirona
York, PA, US - Received
- July 5, 2019
- Decision date
- October 3, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LQY – Locator, Root Apex
- Device class
- Unclassified
Other 510(k)s with product code LQY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252224 | Apex Locator (FindPex)LQY · Traditional | Changzhou Sifary Medical Technology Co., Ltd. | 04/08/2026SE |
| K242383 | Apex LocatorLQY · Traditional | Shenzhen Rogin Medical Co., Ltd. | 03/07/2025SE |
| K242765 | Electronic Apex Locator (Alpha Apex I)LQY · Traditional | Shenzhen Superline Technology Co., Ltd. | 01/17/2025SE |
| K231990 | Apex LocatorLQY · Traditional | Cefla S.C. | 02/13/2024SE |
| K232717 | Apex Locator (AL-Pex), Apex Locator (AL-Pex+)LQY · Traditional | Changzhou Haili Medical Co., Ltd. | 12/22/2023SE |
| K212178 | Root Apex LocatorLQY · Traditional | Foshan Coxo Medical Instrument Co., Ltd. | 07/20/2022SE |
| K210789 | Eq-PexLQY · Traditional | Meta Systems Co., Ltd. | 10/20/2021SE |
| K203836 | BOMEDENT Apex locator, WISMY Apex locatorLQY · Traditional | Changzhou Bomedent Medical Technology Co.,Ltd | 03/30/2021SE |
| K181087 | Apex Locator, DPEX IIILQY · Traditional | Guilin Woodpecker Medical Instrument Co., Ltd. | 12/18/2018SE |
| K171867 | Drs Finder NEOLQY · Traditional | Good Doctors Co., Ltd. | 03/30/2018SE |
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Questions and answers
When was Propex IQ Apex Locator cleared by the FDA?
Propex IQ Apex Locator (K191806) received a 510(k) decision of Substantially Equivalent on October 3, 2019, 90 days after the submission was received.
What is the product code of K191806?
The FDA product code is LQY – Locator, Root Apex, a Unclassified device.