Cleared Traditional

KAVO SYSTEMATICA 1060

K940950 · Kavo America · Dental
Dec 1994
Decision
304d
Days
Class 1
Risk

About This 510(k) Submission

K940950 is an FDA 510(k) clearance for the KAVO SYSTEMATICA 1060, a Chair, Dental, With Operative Unit (Class I — General Controls, product code KLC), submitted by Kavo America (Lake Zurich, US). The FDA issued a Cleared decision on December 29, 1994, 304 days after receiving the submission on February 28, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.6250.

Submission Details

510(k) Number K940950 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 1994
Decision Date December 29, 1994
Days to Decision 304 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

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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