Cleared Traditional

K854042 - RESIN TRAY IMPRESSION MATERIAL (FDA 510(k) Clearance)

Class I Dental device.

K854042 · Dentsply Intl. · Dental device
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Nov 1985
Decision
36d
Days
Class 1
Risk

K854042 is an FDA 510(k) clearance for the RESIN TRAY IMPRESSION MATERIAL. Classified as Material, Impression Tray, Resin (product code EBH), Class I - General Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on November 7, 1985 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3670 - 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 Dentsply Intl. devices

Submission Details

510(k) Number K854042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1985
Decision Date November 07, 1985
Days to Decision 36 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 127d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBH Material, Impression Tray, Resin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3670
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.