Cleared Traditional

K033597 - ATR 5000, LC 5000, IMPLANT SYSTEM

K033597 is an FDA 510(k) clearance for ATR 5000, manufactured by Advanced Technology Research (A.T.R.) S.R.L.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K033597 · Advanced Technology Research (A.T.R.) S.R.L. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
11d
Days
Class 1
Risk

K033597 is an FDA 510(k) clearance for the ATR 5000, LC 5000, IMPLANT SYSTEM. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Advanced Technology Research (A.T.R.) S.R.L. (Pistoia, IT). The FDA issued a Cleared decision on November 25, 2003 after a review of 11 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 Advanced Technology Research (A.T.R.) S.R.L. devices

FDA 510(k) Submission Details - K033597

510(k) Number K033597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2003
Decision Date November 25, 2003
Days to Decision 11 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
117d faster than avg
Panel avg: 128d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

EKX Device Classification - Class 1, General Controls

Product Code EKX Handpiece, Direct Drive, Ac-powered
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 - EKX Handpiece, Direct Drive, Ac-powered

All 83
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K033597.
LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE
K050612 · Lightspeed Technology, Inc. · May 2005
TCM ENDO V, MODEL 1534
K042822 · NOUVAG AG · Dec 2004
IMPLANTEO IMPLANTOLOGY MOTOR
K041279 · Anthogyr · Sep 2004
DENTAPORT ZX
K031204 · J. Morita USA, Inc. · Aug 2003
APEX ELECTRIC HANDPIECE SYSTEM
K031540 · Lares Research, Inc. · Jun 2003
ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925
K030163 · Aseptico, Inc. · Mar 2003