Cleared Traditional

K260027 - Firstar Dental Electric Motor

K260027 is an FDA 510(k) clearance for Firstar Dental Electric Motor, manufactured by FDC Technology Industry Co.. The device is a Class 1 Dental device with product code EBW cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K260027 · FDC Technology Industry Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
269d
Days
Class 1
Risk

K260027 is an FDA 510(k) clearance for the Firstar Dental Electric Motor. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by FDC Technology Industry Co. (Kent, US). The FDA issued a Cleared decision on October 1, 2026 after a review of 269 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 FDC Technology Industry Co. devices

FDA 510(k) Submission Details - K260027

510(k) Number K260027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2026
Decision Date October 01, 2026
Days to Decision 269 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
141d slower than avg
Panel avg: 128d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

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 Consultant

Firstar Dental Company
David Yee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBW Controller, Foot, Handpiece And Cord

All 59
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K260027.
Motor Handpiece and Control Unit (SDI10)
K251407 · Saeshin Precision Co., Ltd. · Jan 2026
Star E900 Electric System
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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