Cleared Traditional

K171577 - Smartcord

K171577 · Eastdent Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
338d
Days
-
Risk

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.

View all Eastdent Co., Ltd. devices

FDA 510(k) Submission Details - K171577

510(k) Number K171577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2017
Decision Date May 03, 2018
Days to Decision 338 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
211d slower than avg
Panel avg: 127d · This submission: 338d
Pathway characteristics
Predicate-based equivalence.

MVL Device Classification - Class 0,

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

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