Cleared Traditional

K090369 - PRODRIVE LINE OF DENTAL HANDPIECES

K090369 is an FDA 510(k) clearance for PRODRIVE LINE OF DENTAL HANDPIECES, 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 14-day FDA review.

K090369 · Prodrive Systems, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
14d
Days
Class 1
Risk

K090369 is an FDA 510(k) clearance for the PRODRIVE LINE OF DENTAL HANDPIECES. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Prodrive Systems, Inc. (Ogdensburg, US). The FDA issued a Cleared decision on February 27, 2009 after a review of 14 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 - K090369

510(k) Number K090369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2009
Decision Date February 27, 2009
Days to Decision 14 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
114d faster than avg
Panel avg: 128d · This submission: 14d
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 K090369.
EMS AIR-FLOW HANDY PERIO
K092289 · E.M.S Electro Medical Systems S.A · Oct 2009
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
K091065 · J. Morita USA, Inc. · Oct 2009
CONTRA-ANGLE HANDPIECE KOMET OS30
K090548 · W&H Dentalwerk Buermoos GmbH · Jun 2009
PREMIUM SLOW SPEED
K083101 · Sable Industries, Inc. · Feb 2009
EMS AIR-FLOW MASTER
K082791 · E.M.S Electro Medical Systems S.A · Feb 2009
CARE3 PLUS
K081811 · Nakanishi, Inc. · Jan 2009
K090369 · PRODRIVE LINE OF DENTAL HANDPIECES
Download PDF FDA Summary Prodrive Systems, Inc.