Cleared Special

EVO 700 series high speed handpiece (K232243) - FDA 510(k) Clearance

Class I Dental device.

K232243 · Ttbio Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
26d
Days
Class 1
Risk

K232243 is an FDA 510(k) clearance for the EVO 700 series high speed handpiece. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Ttbio Corp. (Taichung, CN). The FDA issued a Cleared decision on August 23, 2023 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ttbio Corp. devices

Submission Details

510(k) Number K232243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2023
Decision Date August 23, 2023
Days to Decision 26 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 127d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EFB Handpiece, Air-powered, Dental
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 - EFB Handpiece, Air-powered, Dental

All 36
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K232243.
High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)
K233122 · Litu Tech , Ltd. · Apr 2024
Air Motor (Model name: FX204 M4)
K233308 · Nakanishi, Inc. · Apr 2024
High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors
K220179 · Foshan Coxo Medical Instrument Co., Ltd. · Sep 2023
Titanium Turbine
K230888 · Nakanishi, Inc. · Jun 2023
TRAUS Air Dental Handpiece
K221741 · Saeshin Precision Co., Ltd. · Feb 2023
Medidenta High Speed Handpieces
K202674 · Pac-Dent, Inc. · Dec 2022