Cleared Traditional

K854711 - FIBRELIGHT ILLUMINATING ORAL RETRACTORS (FDA 510(k) Clearance)

Class I Dental device.

K854711 · Downs Surgical , Ltd. · Dental device
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Feb 1986
Decision
95d
Days
Class 1
Risk

K854711 is an FDA 510(k) clearance for the FIBRELIGHT ILLUMINATING ORAL RETRACTORS. Classified as Retractor, All Types (product code EIG), Class I - General Controls.

Submitted by Downs Surgical , Ltd. (Wilmington, US). The FDA issued a Cleared decision on February 25, 1986 after a review of 95 days - within the typical 510(k) review window.

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: 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 Downs Surgical , Ltd. devices

Submission Details

510(k) Number K854711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1985
Decision Date February 25, 1986
Days to Decision 95 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 127d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIG Retractor, All Types
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.