Cleared Traditional

K934783 - KAVO INTRASEPT 905 (FDA 510(k) Clearance)

Class I Dental device.

K934783 · Kavo America · Dental device
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May 1994
Decision
222d
Days
Class 1
Risk

K934783 is an FDA 510(k) clearance for the KAVO INTRASEPT 905. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Kavo America (Lake Zurich, US). The FDA issued a Cleared decision on May 16, 1994 after a review of 222 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Kavo America devices

Submission Details

510(k) Number K934783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1993
Decision Date May 16, 1994
Days to Decision 222 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
95d slower than avg
Panel avg: 127d · This submission: 222d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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.

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