Cleared Traditional

EVO 450 series High Speed Handpieces (K190508) - FDA 510(k) Clearance

Class I Dental device.

K190508 · Ttbio Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
285d
Days
Class 1
Risk

K190508 is an FDA 510(k) clearance for the EVO 450 series High Speed Handpieces. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Ttbio Corp. (Taichung, TW). The FDA issued a Cleared decision on December 11, 2019 after a review of 285 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 Ttbio Corp. devices

Submission Details

510(k) Number K190508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2019
Decision Date December 11, 2019
Days to Decision 285 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
158d slower than avg
Panel avg: 127d · This submission: 285d
Pathway characteristics
Predicate-based equivalence.

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 K190508.
Lubrina 2
K190509 · J. Morita USA, Inc. · Mar 2020
Midwest Rhino XE and Air Motor M
K192409 · Dentsply Sirona · Jan 2020
SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece
K192412 · Dentalez, Inc. · Jan 2020
Dental high speed handpiece, Dental low speed handpiece
K181900 · Foshan Cicada Dental Instrument Co, Ltd. · Dec 2019
PROPHYflex 4
K181110 · Kaltenbach & Voigt GmbH · Apr 2019
Dental High-speed Handpiece and Accessories
K173943 · Microp Technology (Taiwan), Inc. · Jul 2018