Cleared Traditional

K032395 - PROPHY-MATE

K032395 is an FDA 510(k) clearance for PROPHY-MATE, manufactured by Nakanishi, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K032395 · Nakanishi, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
74d
Days
Class 1
Risk

K032395 is an FDA 510(k) clearance for the PROPHY-MATE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Nakanishi, Inc. (Kanuma-Shi, JP). The FDA issued a Cleared decision on October 17, 2003 after a review of 74 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 Nakanishi, Inc. devices

FDA 510(k) Submission Details - K032395

510(k) Number K032395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2003
Decision Date October 17, 2003
Days to Decision 74 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 127d · This submission: 74d
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 161
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K032395.
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
SIROAIR L AIR SCALER
K033812 · Sirona Dental Systems GmbH · Feb 2004
ESTYLUS ELECTRIC MOTOR SYSTEM
K031145 · Dentsply Intl. · Jul 2003
PROPHYPEARLS
K031868 · Kavo America · Jul 2003
KAVO QUATTROCARE
K012308 · Kavo America · Jun 2002