Cleared Traditional

K052515 - SIROENDO

K052515 is an FDA 510(k) clearance for SIROENDO, manufactured by Sirona Dental Systems GmbH. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K052515 · Sirona Dental Systems GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
198d
Days
Class 1
Risk

K052515 is an FDA 510(k) clearance for the SIROENDO. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Sirona Dental Systems GmbH (North Attleboro, US). The FDA issued a Cleared decision on March 31, 2006 after a review of 198 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Sirona Dental Systems GmbH devices

FDA 510(k) Submission Details - K052515

510(k) Number K052515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2005
Decision Date March 31, 2006
Days to Decision 198 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 127d · This submission: 198d
Pathway characteristics
Predicate-based equivalence.

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 70
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K052515.
CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR
K090931 · W&H Dentalwerk Buermoos GmbH · Dec 2009
ROOT ZX II
K071190 · J. Morita USA, Inc. · Aug 2007
POWERTOME PERIOTOME
K063007 · Westport Medical, Inc. · Oct 2006
IMPLANT HANDPIECES
K051661 · Sirona Dental Systems GmbH · Sep 2005
LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE
K050612 · Lightspeed Technology, Inc. · May 2005
TCM ENDO V, MODEL 1534
K042822 · NOUVAG AG · Dec 2004