Cleared Traditional

K902018 - DENTAURUM CERAMIC DEBONDING UNIT

K902018 is an FDA 510(k) clearance for DENTAURUM CERAMIC DEBONDING UNIT, manufactured by Dentauraum, Inc.. The device is a Class 1 Dental device with product code EKS cleared through the Traditional 510(k) pathway after a 335-day FDA review.

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

FDA 510(k) Submission Details - K902018

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 127d · This submission: 335d
Pathway characteristics
Predicate-based equivalence.

EKS Device Classification - Class 1, General Controls

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.