Cleared Traditional

VEGA DENTAL OPERATING LIGHT

K854646 · Alpine Dental Equipment Co. · Dental
Mar 1986
Decision
107d
Days
Class 1
Risk

About This 510(k) Submission

K854646 is an FDA 510(k) clearance for the VEGA DENTAL OPERATING LIGHT, a Light, Surgical Headlight (Class I — General Controls, product code EBA), submitted by Alpine Dental Equipment Co. (East Orange, US). The FDA issued a Cleared decision on March 6, 1986, 107 days after receiving the submission on November 19, 1985. This device falls under the Dental review panel. Regulated under 21 CFR 872.4630.

Submission Details

510(k) Number K854646 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1985
Decision Date March 06, 1986
Days to Decision 107 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EBA — Light, Surgical Headlight
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4630

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