Apex Locator
FDA 510(k) K231990 · Cefla S.C.
510(k) numberK231990
Submission
- Device name
- Apex Locator
- Applicant
- Cefla S.C.
Imola, IT - Received
- July 5, 2023
- Decision date
- February 13, 2024
- 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 |
| 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 |
| K191806 | Propex IQ Apex LocatorLQY · Traditional | Dentsply Sirona | 10/03/2019SE |
| 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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| K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER…EBW · Traditional | 05/09/2022SE |
| K220664 | NewTom 7GJAK · Traditional | 05/06/2022SE |
| K214084 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS · Special | 01/20/2022SE |
| K200688 | hyperion X5, NewTom GO, X-RADiUS COMPACTOAS · Traditional | 04/09/2020SE |
| K190496 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS · Traditional | 04/24/2019SE |
| K183448 | NewTom 5G XLJAK · Traditional | 03/08/2019SE |
Questions and answers
When was Apex Locator cleared by the FDA?
Apex Locator (K231990) received a 510(k) decision of Substantially Equivalent on February 13, 2024, 223 days after the submission was received.
What is the product code of K231990?
The FDA product code is LQY – Locator, Root Apex, a Unclassified device.