K210789 - EQ-PEX (FDA 510(k) Clearance)

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