Cleared Traditional

K123608 - ENDO E CLASS (FDA 510(k) Clearance)

Class I Dental device.

K123608 · Saeyang Microtech Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
268d
Days
Class 1
Risk

K123608 is an FDA 510(k) clearance for the ENDO E CLASS. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Saeyang Microtech Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on August 16, 2013 after a review of 268 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Saeyang Microtech Co., Ltd. devices

Submission Details

510(k) Number K123608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2012
Decision Date August 16, 2013
Days to Decision 268 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 127d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 60
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K123608.
Motor Handpiece and Control Unit (SDI10)
K251407 · Saeshin Precision Co., Ltd. · Jan 2026
Star E900 Electric System
K251701 · Dentalez, Inc., Stardental Division · Jan 2026
Motor and Apex Module (MaAM)
K251811 · Dentsply Sirona, Inc. · Aug 2025
ELEC ENGINE (Model: ISE-170L)
K231562 · Micro-Nx Co., Ltd. · Jul 2025
Dental Implant Unit
K242646 · Guilin Aesthedent Medical Instruments Co., Ltd. · Apr 2025
NLZ Built-In Motor System
K233288 · Nakanishi, Inc. · Jun 2024