EQ-PEX
FDA 510(k) clearance K210789 · decided 2021-10-20
Clearance details
- K-number
- K210789
- Device name
- EQ-PEX
- Applicant
- Meta Systems Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-03-16
- Decision date
- 2021-10-20
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- LQY
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Seongnam-Si, KR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Apex Locator (FindPex) (K252224) | Changzhou Sifary Medical Technology Co., Ltd. | 2026-04-08 |
| Apex Locator (K242383) | Shenzhen Rogin Medical Co., Ltd. | 2025-03-07 |
| Electronic Apex Locator (Alpha Apex I) (K242765) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 2025-01-17 |
| Apex Locator (K231990) | Cefla S.C. | 2024-02-13 |
| Apex Locator (AL-Pex), Apex Locator (AL-Pex+) (K232717) | Changzhou Haili Medical Co., Ltd. | 2023-12-22 |
| Root Apex Locator (K212178) | Foshan Coxo Medical Instrument Co., Ltd. | 2022-07-20 |
| BOMEDENT Apex locator, WISMY Apex locator (K203836) | Changzhou Bomedent Medical Technology Co.,Ltd | 2021-03-30 |
| Propex IQ Apex Locator (K191806) | Dentsply Sirona | 2019-10-03 |
| Apex Locator, DPEX III (K181087) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2018-12-18 |
| Dr’s Finder NEO (K171867) | Good Doctors Co., Ltd. | 2018-03-30 |
| Dr's Finder (K151274) | Good Doctors Co., Ltd. | 2016-02-04 |
| RAYPEX 6 (K131907) | Dentsply International, Inc. | 2014-01-31 |
Recalls involving this device
No recalls on record reference this clearance.