Cleared Traditional

DE-BOND 200 (K883418) - FDA 510(k) Clearance

Class I Dental device.

K883418 · Scheu-Dental · Dental device
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Oct 1989
Decision
435d
Days
Class 1
Risk

K883418 is an FDA 510(k) clearance for the DE-BOND 200. Classified as File, Pulp Canal, Endodontic (product code EKS), Class I - General Controls.

Submitted by Scheu-Dental (Washington, US). The FDA issued a Cleared decision on October 24, 1989 after a review of 435 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Scheu-Dental devices

Submission Details

510(k) Number K883418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1988
Decision Date October 24, 1989
Days to Decision 435 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
308d slower than avg
Panel avg: 127d · This submission: 435d
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.