Cleared Traditional

K954012 - DISPOSABLE PROPHY HANDPIECE

K954012 is an FDA 510(k) clearance for DISPOSABLE PROPHY HANDPIECE, manufactured by Denticator Intl., Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K954012 · Denticator Intl., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
75d
Days
Class 1
Risk

K954012 is an FDA 510(k) clearance for the DISPOSABLE PROPHY HANDPIECE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Denticator Intl., Inc. (Rancho Cordova, US). The FDA issued a Cleared decision on November 8, 1995 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 Denticator Intl., Inc. devices

FDA 510(k) Submission Details - K954012

510(k) Number K954012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1995
Decision Date November 08, 1995
Days to Decision 75 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
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.

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 195
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K954012.
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