Cleared Traditional

K013185 - TCM ENDO III

K013185 is an FDA 510(k) clearance for TCM ENDO III, manufactured by NOUVAG AG. The device is a Class 1 Dental device with product code EFA cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K013185 · NOUVAG AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
65d
Days
Class 1
Risk

K013185 is an FDA 510(k) clearance for the TCM ENDO III. Classified as Handpiece, Belt And/or Gear Driven, Dental (product code EFA), Class I - General Controls.

Submitted by NOUVAG AG (Orange, US). The FDA issued a Cleared decision on November 28, 2001 after a review of 65 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 NOUVAG AG devices

FDA 510(k) Submission Details - K013185

510(k) Number K013185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2001
Decision Date November 28, 2001
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 127d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

EFA Device Classification - Class 1, General Controls

Product Code EFA Handpiece, Belt And/or Gear Driven, Dental
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 - EFA Handpiece, Belt And/or Gear Driven, Dental

All 8
Devices cleared under the same product code (EFA) and FDA review panel - the closest regulatory comparables to K013185.
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