Cleared Traditional

SYLVAN DENTAL HEADLIGHT SYSTEM (K923949) - FDA 510(k) Clearance

Class I Dental device.

K923949 · Sylvan Medical Fiberoptics · Dental device
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Oct 1992
Decision
72d
Days
Class 1
Risk

K923949 is an FDA 510(k) clearance for the SYLVAN DENTAL HEADLIGHT SYSTEM. Classified as Light, Surgical Headlight (product code EBA), Class I - General Controls.

Submitted by Sylvan Medical Fiberoptics (North Huntingdon, US). The FDA issued a Cleared decision on October 16, 1992 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4630 - 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.

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Submission Details

510(k) Number K923949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1992
Decision Date October 16, 1992
Days to Decision 72 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 127d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBA Light, Surgical Headlight
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4630
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.