Cleared Traditional

SOLAR F

K854641 · Alpine Dental Equipment Co. · Dental
Mar 1986
Decision
111d
Days
Class 1
Risk

About This 510(k) Submission

K854641 is an FDA 510(k) clearance for the SOLAR F, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Alpine Dental Equipment Co. (East Orange, US). The FDA issued a Cleared decision on March 10, 1986, 111 days after receiving the submission on November 19, 1985. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K854641 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1985
Decision Date March 10, 1986
Days to Decision 111 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EIA — Unit, Operative Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640

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