Cleared Traditional

K852182 - EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER (FDA 510(k) Clearance)

Class I Dental device.

K852182 · The S. S. White Co. · Dental device
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Jul 1985
Decision
43d
Days
Class 1
Risk

K852182 is an FDA 510(k) clearance for the EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER. Classified as Material, Impression Tray, Resin (product code EBH), Class I - General Controls.

Submitted by The S. S. White Co. (Holmdel, US). The FDA issued a Cleared decision on July 2, 1985 after a review of 43 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 The S. S. White Co. devices

Submission Details

510(k) Number K852182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1985
Decision Date July 02, 1985
Days to Decision 43 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 127d · This submission: 43d
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.