Cleared Traditional

DENTAURUM CERAMIC DEBONDING UNIT (K902018) - FDA 510(k) Clearance

Class I Dental device.

K902018 · Dentauraum, Inc. · Dental device
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Apr 1991
Decision
335d
Days
Class 1
Risk

K902018 is an FDA 510(k) clearance for the DENTAURUM CERAMIC DEBONDING UNIT. Classified as File, Pulp Canal, Endodontic (product code EKS), Class I - General Controls.

Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on April 3, 1991 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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. Elevated predicate reliance profile. 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 Dentauraum, Inc. devices

Submission Details

510(k) Number K902018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1990
Decision Date April 03, 1991
Days to Decision 335 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 127d · This submission: 335d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKS File, Pulp Canal, Endodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.