Cleared Traditional

K851136 - TROPHY COMPACT - DENTAL UNIT (FDA 510(k) Clearance)

Class I Dental device.

K851136 · Trophy Radiologie · Dental device
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Jul 1985
Decision
132d
Days
Class 1
Risk

K851136 is an FDA 510(k) clearance for the TROPHY COMPACT - DENTAL UNIT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Trophy Radiologie (Vincennes, Cedex (Paris), FR). The FDA issued a Cleared decision on July 31, 1985 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Trophy Radiologie devices

Submission Details

510(k) Number K851136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1985
Decision Date July 31, 1985
Days to Decision 132 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 127d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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.

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