Cleared Traditional

K883418 - DE-BOND 200

K883418 is an FDA 510(k) clearance for DE-BOND 200, manufactured by Scheu-Dental. The device is a Class 1 Dental device with product code EKS cleared through the Traditional 510(k) pathway after a 435-day FDA review.

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

FDA 510(k) Submission Details - K883418

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.

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.

Regulatory Peers - EKS File, Pulp Canal, Endodontic

All 10
Devices cleared under the same product code (EKS) and FDA review panel - the closest regulatory comparables to K883418.
SHAPING HEDSTROM N.T.
K953604 · Sybron Dental Specialties, Inc. · Sep 1995
DENTAURUM CERAMIC DEBONDING UNIT
K902018 · Dentauraum, Inc. · Apr 1991
VISIONER 21-A
K901037 · J. Morita USA, Inc. · Aug 1990
DENTAL INSTRUMENTS - FILES
K823316 · Miltex, Inc. · Nov 1982
DENTAL INSTRUMENTS - EXCAVATORS
K823318 · Miltex, Inc. · Nov 1982
FILE, PULP CANAL
K800293 · Ipco Corp. · Feb 1980