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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 128d · 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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 240
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K062219.
JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU
K062740 · Jindell Medical Instruments Co., Ltd. · Nov 2006
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K063110 · Shanghai Dental Instrument Factory · Oct 2006
K-SPRAY, MODEL 085-2715
K062418 · Scican · Oct 2006
INTERPROXIMAL REDUCTION SYSTEM
K053368 · Dentsply International · Mar 2006
DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202
K052822 · Thunder Tiger Corp. · Jan 2006
PANA-SPRAY
K052700 · Nsk America Corp. · Dec 2005
K062219 · PRODRIVE SYSTEMS REPLACEMENT TURBINE
Download PDF FDA Summary Prodrive Systems, Inc.