K203836 - BOMEDENT Apex locator, WISMY Apex locator (FDA 510(k) Clearance)

K203836 is an FDA 510(k) clearance for the BOMEDENT Apex locator, WISMY Apex locator. Classified as Locator, Root Apex (product code LQY).

Submitted by Changzhou Bomedent Medical Technology Co.,Ltd (Changzhou, CN). The FDA issued a Cleared decision on March 30, 2021 after a review of 90 days - within the typical 510(k) review window.

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.

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