Cleared Traditional

SKEMA (DENTAL UNIT)

K880475 · Alpine Dental Equipment Co. · Dental
Sep 1988
Decision
232d
Days
Class 1
Risk

About This 510(k) Submission

K880475 is an FDA 510(k) clearance for the SKEMA (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 September 23, 1988, 232 days after receiving the submission on February 4, 1988. This device falls under the Dental review panel. Regulated under 21 CFR 872.6250.

Submission Details

510(k) Number K880475 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 1988
Decision Date September 23, 1988
Days to Decision 232 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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