K181087 - Apex Locator, DPEX III (FDA 510(k) Clearance)

K181087 is an FDA 510(k) clearance for the Apex Locator, DPEX III. Classified as Locator, Root Apex (product code LQY).

Submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Guilin City, CN). The FDA issued a Cleared decision on December 18, 2018 after a review of 237 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.

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