K171577 - Smartcord, Smartcord X (FDA 510(k) Clearance)

K171577 is an FDA 510(k) clearance for the Smartcord, Smartcord X. Classified as Cord, Retraction (product code MVL).

Submitted by Eastdent Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on May 3, 2018 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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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