Cleared Traditional

K111616 - E-CUBE

K111616 is an FDA 510(k) clearance for E-CUBE, manufactured by Saeshin Precision Co., Ltd.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K111616 · Saeshin Precision Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
70d
Days
Class 1
Risk

K111616 is an FDA 510(k) clearance for the E-CUBE. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on August 19, 2011 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Saeshin Precision Co., Ltd. devices

FDA 510(k) Submission Details - K111616

510(k) Number K111616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2011
Decision Date August 19, 2011
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

EKX Device Classification - Class 1, General Controls

Product Code EKX Handpiece, Direct Drive, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKX Handpiece, Direct Drive, Ac-powered

All 46
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