Cleared Traditional

GOLD AIR, GOLD LIGHT

K854645 · Alpine Dental Equipment Co. · Dental
Mar 1986
Decision
113d
Days
Class 1
Risk

About This 510(k) Submission

K854645 is an FDA 510(k) clearance for the GOLD AIR, GOLD LIGHT, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Alpine Dental Equipment Co. (East Orange, US). The FDA issued a Cleared decision on March 12, 1986, 113 days after receiving the submission on November 19, 1985. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K854645 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1985
Decision Date March 12, 1986
Days to Decision 113 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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