Cleared Traditional

K042822 - TCM ENDO V, MODEL 1534

K042822 is an FDA 510(k) clearance for TCM ENDO V, manufactured by NOUVAG AG. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K042822 · NOUVAG AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
71d
Days
Class 1
Risk

K042822 is an FDA 510(k) clearance for the TCM ENDO V, MODEL 1534. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by NOUVAG AG (Gebenstorf, CH). The FDA issued a Cleared decision on December 22, 2004 after a review of 71 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 - K042822

510(k) Number K042822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2004
Decision Date December 22, 2004
Days to Decision 71 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
57d faster than avg
Panel avg: 128d · This submission: 71d
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 85
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K042822.
SIROENDO
K052515 · Sirona Dental Systems GmbH · Mar 2006
IMPLANT HANDPIECES
K051661 · Sirona Dental Systems GmbH · Sep 2005
LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE
K050612 · Lightspeed Technology, Inc. · May 2005
IMPLANTEO IMPLANTOLOGY MOTOR
K041279 · Anthogyr · Sep 2004
OSSTELL MENTOR RFA
K033689 · Integration Diagnostics, Ltd. · Feb 2004
ATR 5000, LC 5000, IMPLANT SYSTEM
K033597 · Advanced Technology Research (A.T.R.) S.R.L. · Nov 2003
K042822 · TCM ENDO V, MODEL 1534
Download PDF FDA Summary NOUVAG AG