Cleared Traditional

K210789 - EQ-PEX

K210789 · Meta Systems Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
218d
Days
-
Risk

K210789 is an FDA 510(k) clearance for the EQ-PEX. Classified as Locator, Root Apex (product code LQY).

Submitted by Meta Systems Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on October 20, 2021 after a review of 218 days - an extended review cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Meta Systems Co., Ltd. devices

FDA 510(k) Submission Details - K210789

510(k) Number K210789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2021
Decision Date October 20, 2021
Days to Decision 218 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 127d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

LQY Device Classification - Class 0,

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 19
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K210789.
Apex Locator
K231990 · Cefla S.C. · Feb 2024
Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
K232717 · Changzhou Haili Medical Co., Ltd. · Dec 2023
Root Apex Locator
K212178 · Foshan Coxo Medical Instrument Co., Ltd. · Jul 2022
BOMEDENT Apex locator, WISMY Apex locator
K203836 · Changzhou Bomedent Medical Technology Co.,Ltd · Mar 2021
Propex IQ Apex Locator
K191806 · Dentsply Sirona · Oct 2019
Apex Locator, DPEX III
K181087 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dec 2018