Cleared Traditional

POLO DENTAL UNIT

K854647 · Alpine Dental Equipment Co. · Dental
Jun 1986
Decision
198d
Days
Class 1
Risk

About This 510(k) Submission

K854647 is an FDA 510(k) clearance for the POLO DENTAL UNIT, a Chair, Dental, With Operative Unit (Class I — General Controls, product code KLC), submitted by Alpine Dental Equipment Co. (East Orange, US). The FDA issued a Cleared decision on June 5, 1986, 198 days after receiving the submission on November 19, 1985. This device falls under the Dental review panel. Regulated under 21 CFR 872.6250.

Submission Details

510(k) Number K854647 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1985
Decision Date June 05, 1986
Days to Decision 198 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code KLC — Chair, Dental, With Operative Unit
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6250

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