Cleared Traditional

K112024 - TI-MAX X450

K112024 is the FDA 510(k) clearance for TI-MAX X450 by Nakanishi, Inc.. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 341-day FDA review.

K112024 · Nakanishi, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
341d
Days
Class 1
Risk

K112024 is an FDA 510(k) clearance for the TI-MAX X450. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Nakanishi, Inc. (Richardson, US). The FDA issued a Cleared decision on June 20, 2012 after a review of 341 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Nakanishi, Inc. devices

Submission Details

510(k) Number K112024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2011
Decision Date June 20, 2012
Days to Decision 341 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
214d slower than avg
Panel avg: 127d · This submission: 341d
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 77
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K112024.
Concentrix MX-AC High-Speed Handpiece
K173465 · Dentalez, Inc. · Mar 2018
PANA SPRAY Plus
K163483 · Nakanishi, Inc. · Aug 2017
T1/T2/T3 TURBINE FAMILY
K131319 · Sirona Dental Systems GmbH · May 2014
TI-MAX X TURBINE
K113655 · Nakanishi, Inc. · Mar 2012
PROPHY-MATE NEO
K112673 · Nakanishi, Inc. · Feb 2012
BOSWORTH AIR POLISHER
K100731 · Harry J. Bosworth Co. · Dec 2010