Cleared Traditional

K032395 - PROPHY-MATE

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

K032395 · Nakanishi, Inc. · Dental device
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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

Submission Details

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.

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 K032395.
TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE
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SIROAIR L AIR SCALER
K033812 · Sirona Dental Systems GmbH · Feb 2004
ESTYLUS ELECTRIC MOTOR SYSTEM
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TULSA CONTRA ANGLES
K012720 · Dentsply Intl. · Nov 2001
W & H ASSISTINA
K010127 · A-Dec, Inc. · Oct 2001