Cleared Traditional

K063007 - POWERTOME PERIOTOME

K063007 is an FDA 510(k) clearance for POWERTOME PERIOTOME, manufactured by Westport Medical, Inc.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K063007 · Westport Medical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
15d
Days
Class 1
Risk

K063007 is an FDA 510(k) clearance for the POWERTOME PERIOTOME. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Westport Medical, Inc. (Salem, US). The FDA issued a Cleared decision on October 17, 2006 after a review of 15 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 Westport Medical, Inc. devices

FDA 510(k) Submission Details - K063007

510(k) Number K063007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2006
Decision Date October 17, 2006
Days to Decision 15 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
112d faster than avg
Panel avg: 127d · This submission: 15d
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 60
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K063007.
PROSTHODONTIC SCREWDRIVER , MODEL IA-400
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ROOT ZX II
K071190 · J. Morita USA, Inc. · Aug 2007
SIROENDO
K052515 · Sirona Dental Systems GmbH · Mar 2006
IMPLANT HANDPIECES
K051661 · Sirona Dental Systems GmbH · Sep 2005
DENTAPORT ZX
K031204 · J. Morita USA, Inc. · Aug 2003