Cleared Traditional

K062219 - PRODRIVE SYSTEMS REPLACEMENT TURBINE

K062219 is an FDA 510(k) clearance for PRODRIVE SYSTEMS REPLACEMENT TURBINE, manufactured by Prodrive Systems, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 2-day FDA review.

K062219 · Prodrive Systems, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
2d
Days
Class 1
Risk

K062219 is an FDA 510(k) clearance for the PRODRIVE SYSTEMS REPLACEMENT TURBINE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Prodrive Systems, Inc. (Spencerville, Ontario, CA). The FDA issued a Cleared decision on August 4, 2006 after a review of 2 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 Prodrive Systems, Inc. devices

FDA 510(k) Submission Details - K062219

510(k) Number K062219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2006
Decision Date August 04, 2006
Days to Decision 2 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 127d · This submission: 2d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 114
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K062219.
I-SURGE
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K043497 · J. Morita USA, Inc. · Mar 2005
TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE
K043498 · J. Morita USA, Inc. · Feb 2005