Cleared Traditional

EOS IMPRESSION TRAYS (K896470) - FDA 510(k) Clearance

Class I Dental device.

K896470 · Ivoclar North America, Inc. · Dental device
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Feb 1990
Decision
88d
Days
Class 1
Risk

K896470 is an FDA 510(k) clearance for the EOS IMPRESSION TRAYS. Classified as Tray, Impression, Preformed (product code EHY), Class I - General Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on February 9, 1990 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6880 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ivoclar North America, Inc. devices

Submission Details

510(k) Number K896470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1989
Decision Date February 09, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EHY Tray, Impression, Preformed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6880
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.