Cleared Traditional

K834055 - VANADIUM EXCAVATORS SIZES 0-6

K834055 is an FDA 510(k) clearance for VANADIUM EXCAVATORS SIZES 0-6, manufactured by Henry Schein, Inc.. The device is a Class 1 Dental device with product code EKC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K834055

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.

EKC Device Classification - Class 1, General Controls

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.