Cleared Traditional

K854646 - VEGA DENTAL OPERATING LIGHT

K854646 is an FDA 510(k) clearance for VEGA DENTAL OPERATING LIGHT, manufactured by Alpine Dental Equipment Co.. The device is a Class 1 Dental device with product code EBA cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K854646 · Alpine Dental Equipment Co. · Dental device
Download Printable Device Report (PDF)
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Mar 1986
Decision
107d
Days
Class 1
Risk

K854646 is an FDA 510(k) clearance for the VEGA DENTAL OPERATING LIGHT. Classified as Light, Surgical Headlight (product code EBA), Class I - General Controls.

Submitted by Alpine Dental Equipment Co. (East Orange, US). The FDA issued a Cleared decision on March 6, 1986 after a review of 107 days - within the typical 510(k) review window.

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: 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 Alpine Dental Equipment Co. devices

FDA 510(k) Submission Details - K854646

510(k) Number K854646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1985
Decision Date March 06, 1986
Days to Decision 107 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 128d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

EBA Device Classification - Class 1, General Controls

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.

Regulatory Peers - EBA Light, Surgical Headlight

Devices cleared under the same product code (EBA) and FDA review panel - the closest regulatory comparables to K854646.
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