Cleared Traditional

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

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

Submission Details

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.

Device Classification

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

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