Cleared Abbreviated

K141183 - EVO 500 SERIES HIGH SPEED HANDPIECES/TI...

K141183 is an FDA 510(k) clearance for EVO 500 SERIES HIGH SPEED HANDPIECES/TI..., manufactured by Ttbio Corp.. The device is a Class 1 Dental device with product code EFB cleared through the Abbreviated 510(k) pathway after a 296-day FDA review.

K141183 · Ttbio Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
296d
Days
Class 1
Risk

K141183 is an FDA 510(k) clearance for the EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HAND.... Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Ttbio Corp. (Taichung, Roc, TW). The FDA issued a Cleared decision on February 27, 2015 after a review of 296 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ttbio Corp. devices

FDA 510(k) Submission Details - K141183

510(k) Number K141183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2014
Decision Date February 27, 2015
Days to Decision 296 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 127d · This submission: 296d
Pathway characteristics
Standards-based clearance path.

EFB Device Classification - Class 1, General Controls

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 91
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