Cleared Traditional

K092758 - X-CUBE

K092758 is an FDA 510(k) clearance for X-CUBE, manufactured by Saeshin Precision Co., Ltd.. The device is a Class 1 Dental device with product code EBW cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K092758 · Saeshin Precision Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
12d
Days
Class 1
Risk

K092758 is an FDA 510(k) clearance for the X-CUBE. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on September 21, 2009 after a review of 12 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 - K092758

510(k) Number K092758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2009
Decision Date September 21, 2009
Days to Decision 12 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
115d faster than avg
Panel avg: 127d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

EBW Device Classification - Class 1, General Controls

Product Code EBW Controller, Foot, Handpiece And Cord
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 - EBW Controller, Foot, Handpiece And Cord

All 32
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K092758.
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