Cleared Traditional

K834055 - VANADIUM EXCAVATORS SIZES 0-6 (FDA 510(k) Clearance)

Class I Dental device.

K834055 · Henry Schein, Inc. · Dental device
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Feb 1984
Decision
90d
Days
Class 1
Risk

K834055 is an FDA 510(k) clearance for the VANADIUM EXCAVATORS SIZES 0-6. Classified as Excavator, Dental, Operative (product code EKC), Class I - General Controls.

Submitted by Henry Schein, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Henry Schein, Inc. devices

Submission Details

510(k) Number K834055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1983
Decision Date February 21, 1984
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKC Excavator, Dental, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.