Cleared Traditional

K962543 - ALPHA AIR HANDPIECE

K962543 is the FDA 510(k) clearance for ALPHA AIR HANDPIECE by Nsk Nakanishi, Inc.. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K962543 · Nsk Nakanishi, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
75d
Days
Class 1
Risk

K962543 is an FDA 510(k) clearance for the ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Nsk Nakanishi, Inc. (Tochigi-Ken, JP). The FDA issued a Cleared decision on September 11, 1996 after a review of 75 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 Nsk Nakanishi, Inc. devices

Submission Details

510(k) Number K962543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1996
Decision Date September 11, 1996
Days to Decision 75 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 127d · This submission: 75d
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 78
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K962543.
ENDO-EZE MOTOR AND HANDPIECE
K992380 · Ultradent Products, Inc. · Oct 1999
SYNEA-HS HIGH SPEED-HANDPIECE
K992011 · A-Dec, Inc. · Sep 1999
MODEL MS-2 HANDPIECE
K982050 · Parkell, Inc. · Sep 1998
W&H 900 INCOLIGHT LT HANDPIECE
K944718 · A-Dec, Inc. · Oct 1995
W&H 100 SERIES LOW SPEED
K944719 · A-Dec, Inc. · Oct 1995
W&H ROTO QUICK COUPLINGS
K945734 · A-Dec, Inc. · Oct 1995