Cleared Traditional

K061701 - HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)

K061701 is an FDA 510(k) clearance for HIGH SPEED AIR TURBINE HANDPIECES, manufactured by J. Morita USA, Inc.. The device is a Class 1 Dental device with product code EFA cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K061701 · J. Morita USA, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
70d
Days
Class 1
Risk

K061701 is an FDA 510(k) clearance for the HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H). Classified as Handpiece, Belt And/or Gear Driven, Dental (product code EFA), Class I - General Controls.

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on August 25, 2006 after a review of 70 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.

FDA 510(k) Submission Details - K061701

510(k) Number K061701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2006
Decision Date August 25, 2006
Days to Decision 70 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
58d faster than avg
Panel avg: 128d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

EFA Device Classification - Class 1, General Controls

Product Code EFA Handpiece, Belt And/or Gear Driven, 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 - EFA Handpiece, Belt And/or Gear Driven, Dental

All 23
Devices cleared under the same product code (EFA) and FDA review panel - the closest regulatory comparables to K061701.
STRONG IMPLANT HANDPIECES
K092412 · Saeshin Precision Co., Ltd. · Sep 2009
MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES
K090676 · Anthogyr · May 2009
MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL
K070084 · Est. Anthogyr · Mar 2007
EXCEL HIGH SPEED DENTAL HANDPIECE
K061581 · Orthosource, Inc. · Aug 2006
IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES
K040674 · Anthogyr · Jun 2004
TCM ENDO III
K013185 · NOUVAG AG · Nov 2001
K061701 · HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)
Download PDF FDA Summary J. Morita USA, Inc.