Cleared Traditional

K081191 - TCM ENDO 20

K081191 is an FDA 510(k) clearance for TCM ENDO 20, 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 101-day FDA review.

K081191 · NOUVAG AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
101d
Days
Class 1
Risk

K081191 is an FDA 510(k) clearance for the TCM ENDO 20. 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 August 7, 2008 after a review of 101 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K081191

510(k) Number K081191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2008
Decision Date August 07, 2008
Days to Decision 101 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
27d faster than avg
Panel avg: 128d · This submission: 101d
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 K081191.
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POWERTOME PERIOTOME
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SIROENDO
K052515 · Sirona Dental Systems GmbH · Mar 2006
K081191 · TCM ENDO 20
Download PDF FDA Summary NOUVAG AG