Cleared Traditional

K043498 - TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE

K043498 is an FDA 510(k) clearance for TWIN POWER TURBINE HIGH SPEED AIR TURBI..., manufactured by J. Morita USA, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K043498 · J. Morita USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
61d
Days
Class 1
Risk

K043498 is an FDA 510(k) clearance for the TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on February 16, 2005 after a review of 61 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all J. Morita USA, Inc. devices

FDA 510(k) Submission Details - K043498

510(k) Number K043498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2004
Decision Date February 16, 2005
Days to Decision 61 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
66d faster than avg
Panel avg: 127d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

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 163
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K043498.
PANA-SPRAY
K052700 · Nsk America Corp. · Dec 2005
MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011
K051872 · Mk-Dent GmbH · Oct 2005
AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV
K043497 · J. Morita USA, Inc. · Mar 2005
IS 40 MICROMOTOR
K042787 · Satelec · Dec 2004
CROMAX HIGH SPEED TURBINE HANDPIECE
K041755 · J.R. Medical Technologies, Inc. · Oct 2004
DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125
K041141 · Dentsply Intl. · Jun 2004