Cleared Traditional

K940950 - KAVO SYSTEMATICA 1060 (FDA 510(k) Clearance)

Class I Dental device.

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

K940950 is an FDA 510(k) clearance for the KAVO SYSTEMATICA 1060. Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by Kavo America (Lake Zurich, US). The FDA issued a Cleared decision on December 29, 1994 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6250 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K940950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 127d · This submission: 304d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KLC Chair, Dental, With Operative Unit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6250
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.