Cleared Traditional

TCM 3000 AND TCM ENDO (K981679) - FDA 510(k) Clearance

Class I Dental device.

K981679 · NOUVAG AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
272d
Days
Class 1
Risk

K981679 is an FDA 510(k) clearance for the TCM 3000 AND TCM ENDO. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by NOUVAG AG (Kaufbeuren, DE). The FDA issued a Cleared decision on February 9, 1999 after a review of 272 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 NOUVAG AG devices

Submission Details

510(k) Number K981679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1998
Decision Date February 09, 1999
Days to Decision 272 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
145d slower than avg
Panel avg: 127d · This submission: 272d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, 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 - EFB Handpiece, Air-powered, Dental

All 260
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