Cleared Traditional

K934783 - KAVO INTRASEPT 905

K934783 is an FDA 510(k) clearance for KAVO INTRASEPT 905, manufactured by Kavo America. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 222-day FDA review.

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

FDA 510(k) Submission Details - K934783

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 127d · This submission: 222d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

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.

Regulatory Peers - EIA Unit, Operative Dental

All 178
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K934783.
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